最新FDA21 CFR QSR820 中英文对照版本

21CFRPart820-QualitySystemRegulation中文版第一章—标题21 食品与药物食品与药物管理局健康与人类服务业部门子章节 H 医疗器械第820部品质系统规章子部分A--总则820.1节范围(a)应用性(1)现行优良制造规范（CGMP）的需求在这品质系统规章中被提出。

这部分的需求管控到使用的方法，及用于预期供人类使用之所有成品器械的设计、制造、包装、标示、存贮、安装、及维修服务的设施及控制。

这部分的需求预期用来确保已完成的器械将会安全及有效的且除此外会依循着联邦政府的食品、药品、和化妆品之法案。

这个部分建立合于已完成医疗器械之制造商的基本需求。

如果以这个部分的需求为条件下制造商保证进行最合适的运作，且不管其他，制造商的需要也才会遵守这些合于保证进行运作的需求。

有关等级I的器械，设计管控应用于这些列于820.30(a)(2)的器械。

这个规章不能应用于制造商的零件或是成品器械的部件，但这样的造者是被鼓励于使用这个规章中合适的条款如指导手册。

人类血液及血液成分的制造商不可依循此部分，但依循这章的第606部分。

人类细胞、组织、及细胞组成和组织为基础是属医疗器械部分的产品（HCT/Ps）（定义于这章的1271.3(d)）之制造商，依循这章且也依循提出于这章的第1271部分的子部分之捐赠者-合格性的程序且适用于这章的第1271部分的子部分D的现行优良组织规范程序。

在介于合于第1271部分的规章与这章的其他部分冲突矛盾的事件中，规章在问题中专属合于器械应该取代较为一般的情形。

(2)这部分的条款应合于任何已完成的器械如同这章定义的，预期供人类使用，其可制造、进口、或进口意图在美国的任何州或领土、哥伦比亚地区、或波多黎各共和国。

(3)在这个规章中项目＂哪点适当＂会用到好几次。

当需求具备＂哪点适当＂时，其被认为＂适当的＂除非制造商能提供在其他方面有正当理由的文件。

如果不履行能合理地被预期出未能符合详细说明需求的产品结果或制造商未能实行任何需要的矫正措施，则这个需求是＂适当的＂。

21CFR820.1820.1 范围a)适用性（1）此质量系统规范中包含了有关现行GMP的要求，此规范中所提到的要求是来控制所有用于人体的成品器械的设计、生产、贴签、储存、装配、维修服务以及用于上述环节的设备和控制方法。

此规范中所提的要求主要是为了确保成品器械的安全性和有效性，同时要符合食品，药品和化妆品规范（简称规范）.此规范建立了适用于成品器械生产商的基本要求。

如果一生产品所涉及的只是本规范要求中所指的一部分环节，而非其它，那么此生产商只需符合本规范要求中所指的其涉及领域的要求即可。

就I级器械而言，其设计只适用于820 .30(a)(2)节中所列的那些器械。

此规范不适用于成品器械部件或组成部分生产商，但鼓励此类生产商使用此规范中适合的规定作为指导。

人造血液和血液部件的生产商不划入此节中，但应列入此章的606节中。

《139页》（2）对此规范中的规定适用于此规范中所定义的用于人体的成品器械，即所生产的，进口的或进口至美国任一州，哥伦比亚特区或波多黎哥的产品。

（3）此规范中曾多次提到“合适”字样。

当一要求加上“合适”字样时，那么应认为是“合适”的，除非生产商有其它证明的记录。

当未执行可能倒致产品不符合其特性要求或生产商无法执行必要的改正措施时，此要求便是“合适”的。

b)局限性此节中的质量系统规范是对此章中其它部分规范的补充，除非另外有明确的陈述.如果无法符合所有可适用的规范，不管是此节中的还是此章中其它部分中的，此种情况下，适用于此器械的特殊规范将替代其它常规的可适用要求。

c)权限 820节的建立和发行是在规范中的501，502，510，513，514，515，516，519，520，522，701，704，801，803节前提下进行的（21U.S.C 351，352，360，360c，360d，360e，360h，360i，360j，360l，371，374，381，383）。

如果不符合此规范中任意一可适用的规定，那么根据规范中501(h)节可认为此器械是仿造的。

1.1 概述§820.1 范围(a) 适用性(1) 在这个质量体系规范中描述了现行的生产管理规范的要求(CGMP). 本规范要求规定了所有医用器械成品在设计,制造,包装,标签,贮存,安装和服务中使用的方法,设施和控制.这些要求是为了确保医疗器械成品的安全和有效,并遵从美国食品,药品和化妆品法.本规范提出了适用于医疗器械成品制造商的基本要求.如果某制造商只进行本规范规定的以部分操作,而不进行其他操作,则该制造商仅需执行适用于他所进行操作的那些要求.有关Ⅰ类器械,设计控制仅按在§820.30(a)(2)中列出的要求进行.这个规范不适用于成品组件和零件的制造商,但鼓励这样的制造商使用规范的适当规定作为指导.人类血液制品和血液成分的制造商不属于本规范的管理范围,但属于606的管理范围.(2) 这一规范的规定适用于本规范定义的医疗器械成品,即使用的对象是人的,在美国各州或领地,哥伦比亚特别区或波多黎哥联邦制造,进口或出口的器械成品.(3) 在本规范中,几次使用了短语”适当的地方”. 当要求以”适当的地方”来限制时,如果制造商没有合理的理由来证明不适宜,就认为此要求是”适当的”. 如果不贯彻”适当的”要求,就会导致产品达不到要求或制造商不能采取某些必要的正确措施.(b) 范围这一的质量体系规范和增补在这一规范其他节的条文明确注明用于其他方面的条文除外. 在不可能执行全部适用条文(包括这一节的和这一规范其他节的条文)的情况下,特定的运用于有问题器械的条文将取代其他一般的适用条文.(c) 权威性根据联邦法501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701,704, 801, 803, (21U.S.C.315, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383) 建立和提出了820规范的权威性. 如果没能执行适用规范,可能会导致产生伪劣器械, 根据法规501(h), 对这样的器械和未能执行规范的人都要进行处罚.(d) 外国制造商如果某制造商提供给美国的进口器械,拒绝接受FDA对外国设备进行是否执行本规范的检查,就会出现法规的801(a)节中的后果. 用这样的设备生产出的任何器械,在设计,制造,包装, 标签,贮存,安装或服务方面,使用方法,设备和控制都未遵从法规的520(f)节和本规范的要求. 根据法规501(h), 用这样的设备制造出来的器械都属于伪劣产品.(e) 豁免或更改(1) 任何希望豁免或更改执行某些器械质量体系要求的申请,都要遵从法规520(f)(2)的要求. 申请豁免或更改的过程将依据这一规范§10.30的程序进行,即FDA的管理程序. 以下地址可提供指导: 器械和放射卫生中心, 小制造商处(HFZ-220), 1350 Picca rd Dr., Rockville, MD20850, U.S.A. 电话: 1-800-638-2041或1-301-443-6597, FAX 301-443-8818.(2) 当FDA判定某种更改有益于公众健康时, 就会起草并认可这项更改. 这种更改仅能在一段时间内维持有效, 即当器械仍能满足公众健康需要, 并且如果没有更改,器械不可能制造得非常有效的一段时间内.§820.3 定义(a)法指的是美国食品,药品和化妆品法修正案(secs.201~903, 52Stat.1040 et seq.,修正版21U.S.C.321~394). 在法201中的全部定义都适用于本规定.(b)投诉指的是以某些书面的,电子的或口头的形式表达意见, 认为在配发后的器械在鉴定,质量,耐久性,可靠性,安全性,有效性或性能方面有缺陷.(c)组成指的是原材料,物质,小件,零件,软件,硬件,标签或有包装和标签的成品器械的零配件.(d)控制编号指的是有区别的符号,如字母或数字的不同组合,或以原制造,包装,标签和分发的单个或批量成品的区别符号来分辨.(e)设计历史文件(DHF)指的是描述某医疗器械成品设计过程的有关记录.(f)设计输入是指作为器械设计基础对器械的物理和特性要求.(g)设计输出是指各设计阶段的设计成果和最终的总设计成果. 完成设计输出包括器械,包装和标签,器械主记录.(h)设计评审是指依照依照文件进行广泛,系统的设计评审, 以评价设计要求的适当性,并评价设计达到这些要求的能力,查明问题所在.(i)器械历史记录(DHR)是指医疗器械成品制造过程的记录.(j)器械主记录(DMR)是指包括医疗器械成品的程序和规范的完满记录.(k)建立是指定义,文件(书面的或电子的)和执行情况.(l)器械成品是指适于使用或具有功能的器械或器械附件, 不论是否经过包装,贴标签或灭菌.(m)批是指一种或几种组成或成品器械具有单一类型,型号,类别,尺寸,成分或软件版本,必须在相同条件下制造,并在规定的限度内具有相同的特征和质量.(n)管理职责是指制造商的高级雇员有权建立或改变制造商的质量方针和质量体系.(o)制造商是指设计,制造,构造,装配或加工成品器械的人. 制造商包括但不局限于那些从事灭菌,安装,再贴标签,再制造,再包装或Specification开发商和从事这些工作的外国实体的最初代理人.(p)生产过程副产物是指促进生产过程所用的材料或物质,制造加工过程中的伴随组分或副产品,以残余物或混杂物的形式存在.(q)不合格是指未达到特定的要求.(r)产品是指组成,制造材料,加工过程中器械,成品器械及返回器械.(s)质量是指使器械安全适用的总性质和特征,包括安全性和性能.(t)质量审核是指在规定的时间间隔,以足够的次数,对制造商质量体系进行有组织的自主的检查,检验质量体系行为和结果是否执行质量体系程序,以保证有效地执行程序,达到质量体系目标.(u)质量方针是指有关质量的机构方向和目标,是由负责的管理人员建立的.(v)质量体系是指检查质量管理的组织机构,职责,程序,处理和资源.(w)再加工是指对成品器械进行加工,调节,革新,再包装,再贮存,大大改变了成品器械的性能,安全性规范或用途.(x)返工指的是对不合格产品采取某些措施,以使他在获准配发之前达到指定的DMR要求.(y)规范是指生产,加工,服务或其他行为必须遵守的一些要求.(z)有效性是指通过检查和提供客观证据来证明能始终满足特定的用途.(1)过程确认是指通过客观的证据证明加工生产出的产物或产品始终达到预定的规范.(2)设计确认是指通过客观的证据证明器械规范与使用者的需要和设计的用途相一致.(aa)验证是指通过检查和提供客观证据来证明已经满足指定的要求.§820.5 质量体系各制造商应建立并保持一个质量体系,适合于他们设计或制造的医疗器械,并且达到本规范的要求.1.2 质量体系要求§820.20 管理职责(a)质量方针管理职能机构应建立质量方针目标和质量承诺,并保证质量方针在企业各级人员中的理解,贯彻和持续执行.(b)管理机构各制造商都应建立并维持一个适当的组织机构,以保证器械依照本规范进行设计和生产.(1)职责和权限各制造商都应任命有相应职责,权限和能独立行使职权的人员负责管理,执行和评价质量体系.(2)人员各制造商都应具备足够的合格人员,包括分派培训有素的人员从事管理,执行,评价和内部质量审核等工作,以达到本规范要求.(3)管理者代表管理职能机构应任命其中一员为管理者代表,并在文件中注明.管理者代表不论其他职责如何,必须履行下列职责和权力:i. 确保按本规范要求有效地建立和保持.ii. 向管理机构汇报质量体系进行情况,供其讨论.(c)管理评审管理职能机构应按照建立的程序,以足够的次数定期评审质量体系的适用性和有效性. 以保证质量体系达到本规范要求和制造商建立的质量方针和目标,评审日期和结果应形成文件.(d)质量策划各制造商应编制质量计划,确定与设计和制造的器械相关的质量实践,人员和措施,并建立达到质量要求的规划.(e)质量体系程序各制造商应建立质量体系的各种程序和实施指南,并形成文件.§820.22 质量审核各制造商应建立质量审核的程序,并进行管理,以保证质量体系符合建立的质量体系要求,确定该质量体系的有效性.质量审核应由与审核事物无直接责任的人执行.若有必要时,应采取措施纠正错误措施,包括对有缺陷的事物进行再审核.管理机构对各质量审核的结果及再审核的情况进行复核.提供质量审核日期和结果及再审核的有关文件.§820.25 全体工作人员(a)一般要求各制造商都应具有足够的工作人员,具备必需教育,背景,接受过培训并富有经验,以保证正确履行本节所要求的全部工作.(b)培训各制造商应建立必需培训的程序,保证全部工作人员在经过培训后能胜任他们各自的职责,并提供与培训有关的文件.(1)培训内容还包括使全体工作人员懂得由于错误执行指定工作可能会导致器械产生缺陷.(2)使从事验证和确认工作的全体工作人员能预见可能会发生的缺陷和错误. 1.3 设计控制§820.30 设计控制(a) 总则(1) Ⅱ,III类器械的制造商,以及在本规范(a)(2)段列出的Ⅰ类器械制造商,应建立并保持控制器械设计的方法,以保证达到特定的要求.(2) 下列Ⅰ类器械也需要设计控制.i.计算机软件的自动化机械.ii.下面列出的器械:(b)设计和开发计划各制造商应建立并保持有关设计和开发行为的计划,并规定执行职责.计划应规定提供或输入设计和开发程序的不同组或行为的互换信息.对计划应进行检查,用现代化手段处理并证实设计和开发的进展.(c)设计输入各制造商应建立并保持关于保证器械的设计要求适当的程序,以器械用途为主,包括使用者和病人的需要.该程序应包括关于不完善,不清楚或抵触要求的处理办法.设计输入要求应记录在文件中,并由指定的人进行检查和认可,并提供认可这些要求的日期和个人签名的文件.(d)设计输出各制造商应建立并保持关于确定和提供设计输出文件的程序,并进行执行设计输入要求的适当评价.设计输出程序应包含或制定参照的认可标准,并保证那些设计输出是鉴定器械良好性能所必需的.设计输出应记录在文件中,在获准之前进行评审,并提供有关评审认可日期和签名的文件.(e)设计评审各制造商应建立并保持一套程序, 保证在器械设计开发的适当阶段,按计划评审设计结果,并提供正式文件.评审参加者应包括设计的专业人员对设计阶段负有责任的代表和与设计阶段五直接责任的人和必要的专家.设计评审的结果包括设计鉴定,评审人员和日期,都应记录在设计历史文件(DHF)中.(f)设计验证各制造商应建立并保持验证器械设计的程序.设计验证应证明设计输出达到设计输入要求.设计验证的结果,包括设计方法的鉴定,验证人员和日期,都应当记录在DHF文件中.(g)设计确认各制造商应建立并保持设计确认的程序.应在规定的操作条件下,对试制的单个,批量产品或等同物进行设计确认的确认.设计确认应保证器械满足使用者的需要,并具有预期用途,还应包括产品在实际或设想使用条件下的试验.设计确认还应包括软件确认及适当的时候的风险分析.有关设计确认的结果,包括对设计和设计方法的鉴定,执行人员和日期都应记录在DHF文件中.(h)设计转换各制造商应建立并保持一套程序以确保器械设计正确性体现在一定的生产规范中.(i)设计更改各制造商应建立并保持一套程序,对更改的设计在执行之前进行鉴定,提供有效性文件或适当的地方进行验证,评审和认可.(j)设计历史文件各制造商应建立并保持各种类型器械的DHF. DHF应包含或参照必要的原始记录,来证明设计开发过程与认可的设计计划一致,并遵守本规范要求.1.4 文件控制§820.40 文件控制各制造商应建立并保持本规范所要求的全部文件控制的程序.程序应提供下列内容:(a)文件认可和发布各制造商应在分发达到本规范要求的全部文件之前,委派专人检查适用性和认可情况.应提供有关认可文件的日期和个人签名的文件.达到本规范要求的文件适用于指定的,使用的或其他需要的地方,所有失效的文件应从使用条款中删除.(b)文件更改更改文件应由执行原文件检查和认可的同一职能部门内的人进行检查和认可,除非有另外明确指定人选. 认可的改动应及时地转达给有关人员.各制造商应保留更改文件的记录. 更改记录应包括修改内容,相关文件的鉴定,认可人的签名,认可日期及更改生效的日期.1.5 采购控制§820.50 采购控制各制造商应建立并保持确保所有购买的或收到的产品和服务符合指定要求的程序.(a)对供应商,承包商和咨询机构的评审各制造商应建立一套供应商,承包商和咨询机构必须达到的指定要求.各制造商应:(1)根据指定要求(包括质量要求),评价和选择潜在的供应商,承包商和咨询机构.评价应记录在文件中.(2)根据评价结果,确定对产品,服务,供应商,承包商和咨询机构实施控制的方式和程度.(3)建立和保持可接受的供应商,承包商和咨询机构的记录.(b)采购资料各制造商应对采购的或收到的产品和服务建立并保留关于是否达到质量要求的资料.可能的话,应包括一份协议,关于供应商,承包商和咨询机构同意告知制造商,他们的产品或服务的改变,是制造商可以判断这些改变是否会影响成品器械的质量.采购资料应依照§820.40得到认可.1.6 标识和可追溯性§820.60 标识各制造商为防止混乱应建立并保持在接收,制造,交付和安装各阶段的产品标识程序.§820.65 可追溯性对于生产外科植入人体,支持或维持生命的器械制造商和依照制造商提供的使用说明正确使用时,如果器械运行失败可对使用者造成严重伤害,则应建立并保持对每个或每批产品都有唯一性标识的程序.程序应促进纠正错误措施.这种标识应包括在设计历史文件中.1.7 生产和过程控制§820.70 生产和过程控制(a)总则各制造商应制定,实施,控制并监测生产过程,以保证器械遵守本规范. 在制造加工过程中可能会发生违反规范的地方,制造商应建立并保持必须的生产过程控制的程序,生产过程控制应包括:(1)提供指导文件,标准操作程序(SOP’s),限定方法和生产控制方式;(2)在生产过程中监测和控制加工参数和产品特征;(3)应遵守的指定参考标准或编号;(4)加工和加工设备的认可;(5)工艺要求应阐述在工艺文件中或用通过鉴定和认可的代表性样品来表现.(b)生产和过程的改变各制造商应建立并保持改变规则,方法,加工或步骤的程序.这些改变在执行之前应被验证或在适当时依照§820.75使改变有效,这些行为均应记录在文件中.改变应依照§820.40得到认可.(c)环境控制在有理由认为周围环境条件对产品质量有不利影响时,制造商应建立并保持适当控制环境条件的程序.应定期检查环境控制系统,以核实该系统,包括必需设备的适当性,并正发挥着良好作用.检查应记录在文件中.(d)工作人员如果有理由认为工作人员和产品或环境的接触对产品质量有不利影响时,各制造商应建立并保持对工作人员的健康,卫生习惯,行为和衣着的要求. 各制造商应保证在指定的环境下临时工作的其他人员接受适当的训练或由接受过训练的人进行监督.(e)污染控制各制造商应建立并保持防止对产品质量有不良影响的物质污染设备或产品的程序.(f)厂房应该设计适当厂房,具有足够的空间进行必须的操作,以防止混乱,并保证有序的操作.(g)设备各制造商应保证在制造加工过程中使用的全部设备都达到指定要求,并经过适当设计,建造,放置和安装以利于保养,调试,清洁和使用.(1)保养计划表各制造商应建立并保持调试,清洁和其他设备保养的计划表,以保证达到生产规范.保养行为,包括执行保养行为的日期和人员应记录在文件中.(2)检查各制造商应依照建立的程序进行定期检查,以保证完成设备保养计划.检查日期和执行人员应记录在文件中.(3)调试各制造商应将设备调整限度和允许公差的说明放在需要定期调试的设备商(或附近),或者从事这些调试的工作人员都备有说明.(h)加工过程的副产物在有理由认为某加工过程的副产物对产品质量具有不利影响的情况下,各制造商应建立并保持使用和排除这种副产物的程序,以保证他被排除或减少到不会对产品质量有不利影响的量.排除或减少加工过程的副产物均应记录在在文件中.(i)自动化处理对于生产或质量体系所用的计算机或自动化数据处理系统,制造商应依照已签订的协议书验证计算机软件是否具有预想的用途.修改的软件验证有效后方能批准和发布.验证过程和结果应记录在文件中.§820.72 检验,测量和实验设备(a)检验,测量和实验设备的控制各制造商应保证全部检验,测量和实验设备,包括机械,自动化或电子的检查和试验设备,适合于期望的目的,并有能力生产有价值的产物.各制造商应建立并保持关于保证常规校准,检验,检查和保养设备的程序.该程序应包括操作,防护和存储设备的的规定,以保持实用的精密度和准确性.有关内容均应记录在文件中.(b)校准校准程序应包括对准确度和精密度的准确说明和限值.当未达到准确度和精密度的限值时,应采取有效补救措施重建限值,并要评价是否对器械质量产生不利影响,有关内容要记录在文件中.(1)校准标准用于检验,测量和实验设备的校准标准应参照国家或国际标准.如果国家或国际标准不适用或不可得,制造商应使用一份自主的复制标准.如果没有可用的标准存在,制造商应建立并保持一份内部执行标准.(2)校准记录设备鉴定,校准日期,每次校准的执行人及下一次校准的日期,均应记录在文件中.这些记录应放在每台设备上(或附近),或者使用设备和校准设备的人都备有记录.§820.75 过程确认(a)当过程的结果不能被随后的检验和试验完全验证时,应建立高标准的保证和认可程序使加工过程确认.过程确认和结果,执行日期和执行人的签名,必要的设备,均应记录在文件中.(b)各制造商应建立并保持关于检测和控制确认过程的过程参数的程序,以保证持续达到指定的要求.(1)各制造商应保证由限定的人完成确认过程.(2)确认过程,监测和控制方法及数据,执行日期,必要时完成确认过程的操作者或使用的主要设备均应记录在文件中.(c)当过程确认发生变化或偏差时,制造商应检查并评价过程确认,必要时要使其再确认.有关内容应记录在文件中.1.8 认可行为§820.80 进货,加工过程和成品的认可(a)总则各制造商应建立并保持认可的程序.认可包括检验,试验或其他验证行为.(b)进货认可行为各制造商应建立并保持认可接受进厂产品的程序.对接受进厂的产品应进行检验,试验或其他验证以达到指定要求.认可和拒绝均应记录在文件中.(c)加工过程中产品的认可行为适当的时候,各制造商应建立并保持保证加工过程中的产品达到指定要求的认可程序.这种程序在完成要求的检验,试验或其他验证行为,或者收到必须的认可证明之前,应保证加工过程中产品控制,并记录在文件中.(d)成品认可行为各制造商应建立并保持认可成品的程序,以保证单个或各批成品达到认可标准.成品在认可以前应隔离放置,或以其他方式适当控制.成品在达到以下要求时,才可进行分发:完成DMR的要求;查阅相关数据和文件;指定专人批准许可并签名;注明批准日期.(e)认可记录各制造商应将认可行为记录在文件中.这些记录应包括:执行的认可行为,执行日期,结果,执行认可行为的个人签名,使用的适当设备.这些记录应作为DHR 的一部分内容.§820.86 认可状况各制造商应以适当的方式检验产品的认可状况,以指明产品是否符合认可标准.认可状况的检验应贯穿整个产品制造,包装,标签,安装和服务的过程,以保证只有通过认可的产品才能分发,使用或安装.1.9 不合格品§820.90 不合格品(a)不合格品控制各制造商应建立并保持控制不合格产品的程序.程序中应写明不合格品的标识,记录,评价,隔离和处置.不合格评价包括确定是否需要调查并告知责任人或机构.评价和调查均应记录在文件中.(b)不合格品的评审和处置(1)各制造商应建立并保持评审和批准处置不合格品的职责的程序.程序应阐明评审和处置过程.对不合格品的处置过程应记录在文件中.文件还包括某不合格品是可用的依据及批准人签名.(2)各制造商应建立并保持返工的程序,包括对不合格品返工之后的复试和复评,以保证产品达到现行的认可规范.返工和复评行为,包括确定返工对产品的不良影响,均应记录在DHR文件中.1.10 纠正和预防措施§820.100 纠正和预防措施各制造商应建立和保持实施纠正和预防措施的程序,程序应包括下列要求:(1)分析过程,操作,让步,质量审核报告,质量记录,服务记录,意见,返工产品或其他来源的数据,以查明导致不合格品或其他质量问题的现存和潜在原因.必要的时候,要适当使用统计学方法分析会再发生的质量问题.(2)调查与生产过程和质量体系有关的不合格原因.(3)确定纠正和防止再发生不合格品和其他质量问题的必须措施.(4)验证纠正和防止措施是否有效,并对成品器械无不利影响.(5)执行和记录修改的方法和程序,必须纠正和预防查明的质量问题.(6)保证与质量问题或不合格品有关的信息能传达给那些直接负责保证该产品质量或预防此类问题的有关人员.(7)把查明的质量问题的相关信息和纠正及预防措施提交管理机构评审.(8)纠正和预防措施的全部措施及结果均记录在文件中.1.11 标签和包装的控制§820.120 器械标签各制造商应建立和保持控制标签的程序.(a)标签完整标签的印刷和应用应保持完整,并且在加工,贮存,搬运,分发和使用过程中的物品均应有标签.(b)标签审查指定专人审查标签的准确性,若适用应包括正确的有效期,控制编号,储存说明,搬运说明和其他附加的处理说明.(c)标签存储各制造商应以能够正确鉴别标签的方式储存标签,并防止混乱.(d)标签操作各制造商应控制标签和包装操作以防止混乱.标签和标签操作的单个或批量产品均应记录在DHR文件中.(e)控制编号按§820.65中要求,控制编号应在整个分发过程中附在器械上.§820.130 器械包装各制造商应保证器械的包装和运输容器经一定设计和管理,能保护器械在加工,储存,搬运和分发的通常情况下不致改变或损坏.1.12 搬运,储存,分发和安装§820.140 搬运各制造商应建立并保持在搬运过程中防止发生混乱,损坏,变质,污染或其他对产品的不良影响的程序.§820.150 储存(a)各制造商应建立并保持控制产品储存场地和库房的程序,以防止混淆,损坏,变质,污染或其他在使用和分发以前的不利影响,并保证不使用或分发过期的,废弃的或变质的产品.为防止产品超过保质期,应以能促进货品轮流发送的方式储存,且货架条件应合适.(b)各制造商应建立并保持储存场地的授权接收或发送方法的程序.§820.160 分发(a)各制造商应建立并保持控制分发成品的程序,以保证只分发被认可的器械,不分发已到期或变质的器械,并检查订单,以保证在器械分发之前无混乱和错误.(b)各制造商应建立并保持分发记录,包括下述内容:最初运送的地址和姓名,装运器械的标识和数量,装运日期,器械的控制编号.§820.170 安装(a)需要安装器械的各制造商应建立并保持适当的安装和检查说明书及适当的试验程序.安装说明书和程序随器械一起分发或送给安装者,说明书和程序应包括正确安装的指导方法,使安装后器械能正常使用.。

美国FDA《联邦规章典集》（CFR）第21篇目录（中英文）美国FDA《联邦规章典集》（CFR）第21篇目录中文版概述：美国《联邦规章典集》（Code of Federal Regulations，CFR）第21篇“食品与药品”（Title 21―Food and Drugs）共有9卷（Volume）、3章（Chapter）、1499部（Parts）。

其中：第1―8卷第1章第1―1299部，为健康与人类服务部食品与药品管理局（Food and Drug Administration，Department of Health and Human Services）的规章；第9卷第2章第1300―1399部，为司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）的规章；第9卷第3章第1400―1499部，为毒品控制政策办公室（Office of National Drug Control Policy）的规章。

第21篇“食品与药品”（Title 21―Food and Drugs）的概况卷（Volume）章（Chapter）部（Parts）规制机关（Regulatory Entity）1 Ⅰ1-99 健康与人类服务部食品与药品管理局（FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）2 100-1693 170-1994 200-2995 300-4996 500-5997 600-7998 800-12999 Ⅱ1300-1399 司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）Ⅲ1400-1499 毒品控制政策办公室（Office of National Drug Control Policy）第21篇“食品与药品”（Title 21―Food and Drugs）的章、部目录部(Part) 中译文原英文第Ⅰ章―健康与人类服务部食品与药品管理局（CHAPTER Ⅰ―FOOD AND DRUG AD MINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）第A分章―总则（SUBCHAPTER A―GENERAL）1 一般强制执行规章GENERAL ENFORCEMENT REGULATIONS2 一般行政规则与决定GENERAL ADMINISTRATIVE RULINGS AND DECISIONS3 产品管辖权PRODUCT JURISDICTION5 组织ORGANIZATION7 强制执行政策ENFORCEMENT POLICY10 行政规范与程序ADMINISTRATIVE PRACTICES AND PROCEDURES11 电子化记录；电子化签名ELECTRONIC RECORDS; ELECTRONIC SIGNATURES12 正式证据的公众听证FORMAL EVIDENTIARY PUBLIC HEARING13 在公众质询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY14 在公众咨询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE15 在FDA局长前的公众听证PUBLIC HEARING BEFORE THE COMMISSIONER16 在FDA前的规制性听证REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION17 行政罚款听证CIVIL MONEY PENALTIES HEARINGS19 行为标准与利益冲突STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST20 公共信息PUBLIC INFORMATION21 隐私保护PROTECTION OF PRIVACY25 环境影响考虑ENVIRONMENTAL IMPACT CONSIDERATIONS26 药品良好制造规范报告、医疗器械质量体系核查报告以及某些医疗器械产品评价报告的互认：美国与欧共体MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY50 人类受试者的保护PROTECTION OF HUMAN SUBJECTS54 临床试验者的财务公开FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS56 机构审查委员会INSTITUTIONAL REVIEW BOARDS58 对非临床实验室研究的良好实验室规范GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES60 专利期恢复PATENT TERM RESTORATION70 色素添加剂COLOR ADDITIVES71 色素添加剂申请COLOR ADDITIVE PETITIONS73 免除认证的色素添加剂的列表LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION74 适用认证的色素添加剂的列表LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION80 色素添加剂认证COLOR ADDITIVE CERTIFICATION81 用于食品、药品和化妆品的临时性色素添加剂的一般规范和一般限制GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS82 经认证的临时性列表的色素和规范的列表LISTING OFCERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS83-98 [预留的] [Reserved]99 已上市的药品、生物制品和器械的未经批准的/新的用途的信息的发布DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES第B分章―用于人类消费的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION）100 总则GENERAL101 食品标识FOOD LABELING102 非标准化食品的普通的或者通常的名称COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS 104 食品的营养质量指南NUTRITIONAL QUALITY GUIDELINES FOR FOODS 105 特殊膳食用途的食品FOODS FOR SPECIAL DIETARY USE 106 婴儿配方母乳替代食品质量控制程序INFANT FORMULA QUALITY CONTROL PROCEDURES107 婴儿配方母乳替代食品INFANT FORMULA108 紧急许可控制EMERGENCY PERMIT CONTROL109 在人类食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL110 在制造、包装或者保存人类食品中的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE INMANUFACTURING, PACKING, OR HOLDING HUMAN FOOD 113 装在密封容器中的热加工低酸食品THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS114 酸化食品ACIDIFIED FOODS115 带壳蛋SHELL EGGS119 存在显著或者不合理风险的膳食补充剂DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK120 危害分析与关键控制点（HACCP）体系HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS123 鱼与渔业产品FISH AND FISHERY PRODUCTS129 饮用水加工与装瓶PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER130 食品标准：总则FOOD STANDARDS: GENERAL131 乳与奶油MILK AND CREAM133 乳酪与相关乳酪产品CHEESES AND RELATED CHEESE PRODUCTS135 冷冻点心FROZEN DESSERTS136 烘焙产品BAKERY PRODUCTS137 谷物粉与相关产品CEREAL FLOURS AND RELATED PRODUCTS139 通心粉与面条产品MACARONI AND NOODLE PRODUCTS 145 罐装水果CANNED FRUITS146 罐装水果汁CANNED FRUIT JUICES150 水果黄油、果冻、防腐剂以及相关产品FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS 152 水果馅饼FRUIT PIES155 罐装蔬菜CANNED VEGETABLES156 蔬菜汁VEGETABLE JUICES158 冷冻蔬菜FROZEN VEGETABLES160 蛋与蛋制品EGGS AND EGG PRODUCTS161 鱼与有壳的水生动物FISH AND SHELLFISH163 可可制品CACAO PRODUCTS164 树坚果与花生制品TREE NUT AND PEANUT PRODUCTS165 饮料BEVERAGES166 人造黄油MARGARINE168 增甜剂与餐桌糖浆SWEETENERS AND TABLE SIRUPS169 食品敷料与调味料FOOD DRESSINGS AND FLAVORINGS 170 食品添加剂FOOD ADDITIVES171 食品添加剂申请FOOD ADDITIVE PETITIONS172 允许直接加入用于人类消费食品的食品添加剂FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION173 在用于人类消费的食品中允许的次直接的食品添加剂SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION174 间接食品添加剂：总则INDIRECT FOOD ADDITIVES: GENERAL175 间接食品添加剂：胶粘剂与涂层的组分INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS 176 间接食品添加剂：纸与纸板组分INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS 177 间接食品添加剂：聚合体INDIRECT FOOD ADDITIVES: POLYMERS 178 间接食品添加剂：辅剂、生产助剂和消毒剂INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS179 在食品生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD 180 在额外试验期间临时在食品或者在与食品接触中被允许的食品添加剂FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY181 先前核准的食品配料PRIOR-SANCTIONED FOOD INGREDIENTS182 一般认为安全的物质SUBSTANCES GENERALLYRECOGNIZED AS SAFE184 被确认为一般认为安全的直接食品物质DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 186 被确认为一般认为安全的间接食品物质INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE 189 禁止用于人类食品的物质SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD190 膳食补充剂DIETARY SUPPLEMENTS191-199 [预留的] [Reserved]第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL）200 总则GENERAL201 标识LABELING202 处方药广告PRESCRIPTION DRUG ADVERTISING203 处方药销售PRESCRIPTION DRUG MARKETING205 对批发处方药销售商颁发州执照的指南GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS206 人用固体口服剂型药品的印码IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE 207 药品生产者的登记与商业销售的药品的列表REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION208 处方药的药物治疗指导MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS210 制造、加工、包装或者保存药品的现行良好制造规范；总则CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL211 对完成的药品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHEDPHARMACEUTICALS216 药房配药PHARMACY COMPOUNDING225 对含药饲料的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS 226 对A型含药物品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES 250 对特殊人用药品的特殊要求SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS290 管制的药品CONTROLLED DRUGS299 药品；正式名称与已确定的名称DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES第D分章―人用药品（SUBCHAPTER D―DRUGS FOR HUMAN USE）300 总则GENERAL310 新药NEW DRUGS312 试验用新药申请INVESTIGATIONAL NEW DRUG APPLICATION314 为FDA批准上市新药的申请APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG315 诊断用放射性药品DIAGNOSTIC RADIOPHARMACEUTICALS316 罕见病药ORPHAN DRUGS320 生物利用度与生物等效性要求BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS328 含有酒精的预期用于口部摄入的非处方药品OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL330 一般认为安全与有效以及不错误标识的非处方人用药品OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOTMISBRANDED331 用于非处方的人类使用的抗酸产品ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE 332 用于非处方的人类使用的抗胃肠气胀产品ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE333 用于非处方的人类使用的局部抗菌药品TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE335 用于非处方的人类使用的止泻药品ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE336 用于非处方的人类使用的止吐药品ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE338 用于非处方的人类使用的帮助夜间睡眠的药品NIGHTTIME SLEEP-AID DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE340 用于非处方的人类使用的兴奋药品STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE341 用于非处方的人类使用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE343 用于非处方的人类使用的内服的止痛、退热以及抗风湿药品INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 344 用于非处方的人类使用的局部的耳部药品TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE 346 用于非处方的人类使用的肛肠药品ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE347 用于非处方的人类使用的皮肤保护药品SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE348 用于非处方的人类使用的外部的止痛药品EXTERNAL ANALGESIC DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE349 用于非处方的人类使用的眼科药品OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE350 用于非处方的人类使用的止汗药品ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE352 用于非处方的人类使用的遮光药品SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]355 用于非处方的人类使用的防龋药品ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE357 用于非处方的人类使用的其他内服药品MISCELLANEOUS INTERNAL DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE358 用于非处方的人类使用的其他外用药品MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE361 一般认为安全与有效以及不错误标识的处方人用药品：用于研究的药品PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH369 在用于非处方销售的药品与器械上关于警告的解释性声明INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE370-499 [预留的] [Reserved]第E分章―动物药品、饮料和相关产品（SUBCHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）500 总则GENERAL501 动物食品标识ANIMAL FOOD LABELING502 非标准化的动物食品的普通的或通常的名称COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS 509 在动物食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL510 新动物药NEW ANIMAL DRUGS511 作为试验用途的新动物药NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE514 新动物药申请NEW ANIMAL DRUG APPLICATIONS515 含药饲料厂执照MEDICATED FEED MILL LICENSE520 口服剂型的新动物药ORAL DOSAGE FORM NEW ANIMAL DRUGS522 植入或者注射剂型的新动物药IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 524 眼科和局部剂型的新动物药OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS526 乳房内的剂型INTRAMAMMARY DOSAGE FORMS529 某些其他剂型的新动物药CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS530 在动物中的特别标签药品使用EXTRALABEL DRUG USE IN ANIMALS556 在食品中新动物药残留的容许量TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD558 用于动物饲料的新动物药NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS564 [预留的] [Reserved]570 食品添加剂FOOD ADDITIVES571 食品添加剂申请FOOD ADDITIVE PETITIONS573 在动物饲料与饮用水中允许的食品添加剂FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS579 在动物饲料和宠物食品的生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD582 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE584 在动物饲料与饮用水中被确认为一般认为安全的食品物质FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS589 禁止用于动物食品或者饲料的物质SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED 590-599 [预留的] [Reserved]第F分章―生物制品（SUBCH APTER F―BIOLOGICS）600 生物制品：总则BIOLOGICAL PRODUCTS: GENERAL601 颁发执照LICENSING606 对血液与血液组分的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS607 对人类血液与血液制品的制造者的机构登记与产品列表ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS 610 普通生物制品标准GENERAL BIOLOGICAL PRODUCTS STANDARDS630 对血液、血液组分和血液衍生物的一般要求GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES640 对人类血液和血液制品的附加标准ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS 660 对用于实验室检测的诊断物质的附加标准ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FORLABORATORY TESTS680 对其他产品的附加标准ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS第G分章―化妆品（SUBCHAPTER G―COSMETICS）700 总则GENERAL701 化妆品标识COSMETIC LABELING710 化妆品机构的自愿登记VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS720 化妆品配料构成声明的自愿存档VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS 740 化妆品警告声明COSMETIC PRODUCT WARNING STATEMENTS741-799 [预留的] [Reserved]第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES）800 总则GENERAL801 标识LABELING803 医疗器械报告MEDICAL DEVICE REPORTING806 医疗器械；改正与移动的报告MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS807 对器械的制造者与首次进口者的机构登记与器械列表ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 808 对州和地方医疗器械要求的联邦优先权的豁免EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS809 人用体外诊断产品IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE810 医疗器械召回权MEDICAL DEVICE RECALL AUTHORITY812 试验用器械豁免INVESTIGATIONAL DEVICE EXEMPTIONS 813 [预留的] [Reserved]814 医疗器械的上市前批准PREMARKET APPROVAL OFMEDICAL DEVICES820 质量体系规章QUALITY SYSTEM REGULATION821 医疗器械跟踪要求MEDICAL DEVICE TRACKING REQUIREMENTS822 上市后监视POSTMARKET SURVEILLANCE860 医疗器械分类程序MEDICAL DEVICE CLASSIFICATION PROCEDURES861 性能标准制定程序PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT862 临床化学与临床毒理学器械CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES864 血液学与病理学器械HEMATOLOGY AND PATHOLOGY DEVICES866 免疫学与微生物学器械IMMUNOLOGY AND MICROBIOLOGY DEVICES868 麻醉学器械ANESTHESIOLOGY DEVICES870 心血管器械CARDIOVASCULAR DEVICES872 牙科器械DENTAL DEVICES874 耳、鼻和咽器械EAR, NOSE, AND THROAT DEVICES876 胃肠病学-泌尿学器械GASTROENTEROLOGY-UROLOGY DEVICES878 普通与整形外科器械GENERAL AND PLASTIC SURGERY DEVICES880 普通医院与个人使用器械GENERAL HOSPITAL AND PERSONAL USE DEVICES882 神经学器械NEUROLOGICAL DEVICES884 产科与妇科学器械OBSTETRICAL AND GYNECOLOGICAL DEVICES886 眼科器械OPHTHALMIC DEVICES888 矫形外科器械ORTHOPEDIC DEVICES890 内科学器械PHYSICAL MEDICINE DEVICES892 放射学器械RADIOLOGY DEVICES895 禁止的器械BANNED DEVICES898 电极铅线与患者电缆的性能标准PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES 第I分章―乳房造影质量标准法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDARDS ACT）900 乳房造影法MAMMOGRAPHY第J分章―放射学的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）1000 总则GENERAL1002 记录与报告RECORDS AND REPORTS1003 缺陷与未能守法的通报NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY1004 电子产品的回购、修理或者置换REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS1005 电子产品的进口IMPORTATION OF ELECTRONIC PRODUCTS1010 电子产品的性能标准：总则PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL 1020 电离辐射发生产品的性能标准PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS1030 微波与射电频率发生产品的性能标准PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS1040 发光产品的性能标准PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS1050 声波、次声波和超声波发生产品的性能标准PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS第K分章―[预留的]（SUBCHAPTER K―[RESERVED]）第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）1210 根据《联邦进口乳法》的规章REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT1230 根据《联邦腐蚀性毒物法》的规章REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT1240 传染病的控制CONTROL OF COMMUNICABLE DISEASES 1250 州际运输卫生INTERSTATE CONVEYANCE SANITATION 1251-1269 [预留的] [Reserved]1270 预期用于移植的人体组织HUMAN TISSUE INTENDED FOR TRANSPLANTATION1271 人体细胞、组织以及细胞的和基于组织的产品HUMAN CELLS, TISSUES, AND CELLULAR ANDTISSUE-BASED PRODUCTS1272-1299 [预留的] [Reserved]第Ⅱ章―司法部毒品强制执行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）1300 定义DEFINITIONS1301 管制物质的制造者、分销者和调剂者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES 1303 定额QUOTAS1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS1305 令的格式ORDER FORMS1306 处方PRESCRIPTIONS1307 杂项MISCELLANEOUS1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES1309 表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS1310 列入表的化学品和某些机器的记录与报告RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES 1311 [预留的] [Reserved]1312 管制物质的进口与出口IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES1313 前体与必要化学品的进口与出口IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS 1314-1315 [预留的] [Reserved]1316 行政职能、规范和程序ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES第Ⅲ章―毒品控制政策办公室（CHAPTER Ⅲ―Office of National Drug Control Policy）1400 [预留的] [Reserved]1401 信息的公众可及性PUBLIC AVAILABILITY OF INFORMATION1402 强制性解密审查MANDATORY DECLASSIFICATION REVIEW1403 对给予州和地方政府资金和合作协议的统一行政要求UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS1404 政府范围的排除与暂停（非获得）GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)1405 对无毒品工作场所的政府范围的要求（财政援助）GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)1406-1499 [预留的] [Reserved]。

美国FDA《联邦规章典集》（CFR）第21篇目录中文版概述：美国《联邦规章典集》（Code of Federal Regulations，CFR）第21篇“食品与药品”（Title 21―Food and Drugs）共有9卷（Volume）、3章（Chapter）、1499部（Parts）。

其中：第1―8卷第1章第1―1299部，为健康与人类服务部食品与药品管理局（Food and Drug Administration，Department of Health and Human Services）的规章；第9卷第2章第1300―1399部，为司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）的规章；第9卷第3章第1400―1499部，为毒品控制政策办公室（Office of National Drug Control Policy）的规章。

第21篇“食品与药品”（Title 21―Food and Drugs）的概况卷（Volume）章（Chapter）部（Parts）规制机关（Regulatory Entity）1 Ⅰ1-99 健康与人类服务部食品与药品管理局（FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）2 100-1693 170-1994 200-2995 300-4996 500-5997 600-7998 800-12999 Ⅱ1300-1399 司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）Ⅲ1400-1499 毒品控制政策办公室（Office of National Drug Control Policy）第21篇“食品与药品”（Title 21―Food and Drugs）的章、部目录部(Part) 中译文原英文第Ⅰ章―健康与人类服务部食品与药品管理局（CHAPTER Ⅰ―FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）第A分章―总则（SUBCHAPTER A―GENERAL）1 一般强制执行规章GENERAL ENFORCEMENT REGULATIONS2 一般行政规则与决定GENERAL ADMINISTRATIVE RULINGS AND DECISIONS3 产品管辖权PRODUCT JURISDICTION5 组织ORGANIZATION7 强制执行政策ENFORCEMENT POLICY10 行政规范与程序ADMINISTRATIVE PRACTICES AND PROCEDURES11 电子化记录；电子化签名ELECTRONIC RECORDS; ELECTRONIC SIGNATURES12 正式证据的公众听证FORMAL EVIDENTIARY PUBLIC HEARING13 在公众质询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY14 在公众咨询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE15 在FDA局长前的公众听证PUBLIC HEARING BEFORE THE COMMISSIONER16 在FDA前的规制性听证REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION17 行政罚款听证CIVIL MONEY PENALTIES HEARINGS19 行为标准与利益冲突STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST20 公共信息PUBLIC INFORMATION21 隐私保护PROTECTION OF PRIVACY25 环境影响考虑ENVIRONMENTAL IMPACT CONSIDERATIONS26 药品良好制造规范报告、医疗器械质量体系核查报告以及某些医疗器械产品评价报告的互认：美国与欧共体MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY50 人类受试者的保护PROTECTION OF HUMAN SUBJECTS54 临床试验者的财务公开FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS56 机构审查委员会INSTITUTIONAL REVIEW BOARDS58 对非临床实验室研究的良好实验室规范GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES60 专利期恢复PATENT TERM RESTORATION70 色素添加剂COLOR ADDITIVES71 色素添加剂申请COLOR ADDITIVE PETITIONS73 免除认证的色素添加剂的列表LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION74 适用认证的色素添加剂的列表LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION80 色素添加剂认证COLOR ADDITIVE CERTIFICATION81 用于食品、药品和化妆品的临时性色素添加剂的一般规范和一般限制GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS82 经认证的临时性列表的色素和规范的列表LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS83-98 [预留的] [Reserved]99 已上市的药品、生物制品和器械的未经批准的/新的用途的信息的发布DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES第B分章―用于人类消费的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION）100 总则GENERAL101 食品标识FOOD LABELING102 非标准化食品的普通的或者通常的名称COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS 104 食品的营养质量指南NUTRITIONAL QUALITY GUIDELINES FOR FOODS105 特殊膳食用途的食品FOODS FOR SPECIAL DIETARY USE106 婴儿配方母乳替代食品质量控制程序INFANT FORMULA QUALITY CONTROL PROCEDURES107 婴儿配方母乳替代食品INFANT FORMULA108 紧急许可控制EMERGENCY PERMIT CONTROL109 在人类食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL110 在制造、包装或者保存人类食品中的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE INMANUFACTURING, PACKING, OR HOLDING HUMAN FOOD113 装在密封容器中的热加工低酸食品THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS114 酸化食品ACIDIFIED FOODS115 带壳蛋SHELL EGGS119 存在显著或者不合理风险的膳食补充剂DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK120 危害分析与关键控制点（HACCP）体系HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS123 鱼与渔业产品FISH AND FISHERY PRODUCTS129 饮用水加工与装瓶PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER130 食品标准：总则FOOD STANDARDS: GENERAL131 乳与奶油MILK AND CREAM133 乳酪与相关乳酪产品CHEESES AND RELATED CHEESE PRODUCTS135 冷冻点心FROZEN DESSERTS136 烘焙产品BAKERY PRODUCTS137 谷物粉与相关产品CEREAL FLOURS AND RELATED PRODUCTS139 通心粉与面条产品MACARONI AND NOODLE PRODUCTS145 罐装水果CANNED FRUITS146 罐装水果汁CANNED FRUIT JUICES150 水果黄油、果冻、防腐剂以及相关产品FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS 152 水果馅饼FRUIT PIES155 罐装蔬菜CANNED VEGETABLES156 蔬菜汁VEGETABLE JUICES158 冷冻蔬菜FROZEN VEGETABLES160 蛋与蛋制品EGGS AND EGG PRODUCTS161 鱼与有壳的水生动物FISH AND SHELLFISH163 可可制品CACAO PRODUCTS164 树坚果与花生制品TREE NUT AND PEANUT PRODUCTS165 饮料BEVERAGES166 人造黄油MARGARINE168 增甜剂与餐桌糖浆SWEETENERS AND TABLE SIRUPS169 食品敷料与调味料FOOD DRESSINGS AND FLAVORINGS170 食品添加剂FOOD ADDITIVES171 食品添加剂申请FOOD ADDITIVE PETITIONS172 允许直接加入用于人类消费食品的食品添加剂FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION173 在用于人类消费的食品中允许的次直接的食品添加剂SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION174 间接食品添加剂：总则INDIRECT FOOD ADDITIVES: GENERAL175 间接食品添加剂：胶粘剂与涂层的组分INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS176 间接食品添加剂：纸与纸板组分INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS 177 间接食品添加剂：聚合体INDIRECT FOOD ADDITIVES: POLYMERS178 间接食品添加剂：辅剂、生产助剂和消毒剂INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS179 在食品生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD180 在额外试验期间临时在食品或者在与食品接触中被允许的食品添加剂FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY181 先前核准的食品配料PRIOR-SANCTIONED FOOD INGREDIENTS182 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE184 被确认为一般认为安全的直接食品物质DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE186 被确认为一般认为安全的间接食品物质INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE189 禁止用于人类食品的物质SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD190 膳食补充剂DIETARY SUPPLEMENTS191-199 [预留的] [Reserved]第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL）200 总则GENERAL201 标识LABELING202 处方药广告PRESCRIPTION DRUG ADVERTISING203 处方药销售PRESCRIPTION DRUG MARKETING205 对批发处方药销售商颁发州执照的指南GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS206 人用固体口服剂型药品的印码IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE207 药品生产者的登记与商业销售的药品的列表REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION208 处方药的药物治疗指导MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS210 制造、加工、包装或者保存药品的现行良好制造规范；总则CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL211 对完成的药品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS216 药房配药PHARMACY COMPOUNDING225 对含药饲料的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS226 对A型含药物品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES250 对特殊人用药品的特殊要求SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS290 管制的药品CONTROLLED DRUGS299 药品；正式名称与已确定的名称DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES第D分章―人用药品（SUBCHAPTER D―DRUGS FOR HUMAN USE）300 总则GENERAL310 新药NEW DRUGS312 试验用新药申请INVESTIGATIONAL NEW DRUG APPLICATION314 为FDA批准上市新药的申请APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG315 诊断用放射性药品DIAGNOSTIC RADIOPHARMACEUTICALS316 罕见病药ORPHAN DRUGS320 生物利用度与生物等效性要求BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS328 含有酒精的预期用于口部摄入的非处方药品OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL330 一般认为安全与有效以及不错误标识的非处方人用药品OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED331 用于非处方的人类使用的抗酸产品ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE 332 用于非处方的人类使用的抗胃肠气胀产品ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE333 用于非处方的人类使用的局部抗菌药品TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE335 用于非处方的人类使用的止泻药品ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE336 用于非处方的人类使用的止吐药品ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE338 用于非处方的人类使用的帮助夜间睡眠的药品NIGHTTIME SLEEP-AID DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE340 用于非处方的人类使用的兴奋药品STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE341 用于非处方的人类使用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE343 用于非处方的人类使用的内服的止痛、退热以及抗风湿药品INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE344 用于非处方的人类使用的局部的耳部药品TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE346 用于非处方的人类使用的肛肠药品ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE347 用于非处方的人类使用的皮肤保护药品SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE348 用于非处方的人类使用的外部的止痛药品EXTERNAL ANALGESIC DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE349 用于非处方的人类使用的眼科药品OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE350 用于非处方的人类使用的止汗药品ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE352 用于非处方的人类使用的遮光药品SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]355 用于非处方的人类使用的防龋药品ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE357 用于非处方的人类使用的其他内服药品MISCELLANEOUS INTERNAL DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE358 用于非处方的人类使用的其他外用药品MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE361 一般认为安全与有效以及不错误标识的处方人用药品：用于研究的药品PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH369 在用于非处方销售的药品与器械上关于警告的解释性声明INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE370-499 [预留的] [Reserved]第E分章―动物药品、饮料和相关产品（SUBCHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）500 总则GENERAL501 动物食品标识ANIMAL FOOD LABELING502 非标准化的动物食品的普通的或通常的名称COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS509 在动物食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL510 新动物药NEW ANIMAL DRUGS511 作为试验用途的新动物药NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE514 新动物药申请NEW ANIMAL DRUG APPLICATIONS515 含药饲料厂执照MEDICATED FEED MILL LICENSE520 口服剂型的新动物药ORAL DOSAGE FORM NEW ANIMAL DRUGS522 植入或者注射剂型的新动物药IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS 524 眼科和局部剂型的新动物药OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS526 乳房内的剂型INTRAMAMMARY DOSAGE FORMS529 某些其他剂型的新动物药CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS530 在动物中的特别标签药品使用EXTRALABEL DRUG USE IN ANIMALS556 在食品中新动物药残留的容许量TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD558 用于动物饲料的新动物药NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS564 [预留的] [Reserved]570 食品添加剂FOOD ADDITIVES571 食品添加剂申请FOOD ADDITIVE PETITIONS573 在动物饲料与饮用水中允许的食品添加剂FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS579 在动物饲料和宠物食品的生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD582 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE584 在动物饲料与饮用水中被确认为一般认为安全的食品物质FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS589 禁止用于动物食品或者饲料的物质SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED 590-599 [预留的] [Reserved]第F分章―生物制品（SUBCHAPTER F―BIOLOGICS）600 生物制品：总则BIOLOGICAL PRODUCTS: GENERAL601 颁发执照LICENSING606 对血液与血液组分的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS607 对人类血液与血液制品的制造者的机构登记与产品列表ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS610 普通生物制品标准GENERAL BIOLOGICAL PRODUCTS STANDARDS630 对血液、血液组分和血液衍生物的一般要求GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES640 对人类血液和血液制品的附加标准ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS660 对用于实验室检测的诊断物质的附加标准ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FORLABORATORY TESTS680 对其他产品的附加标准ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS第G分章―化妆品（SUBCHAPTER G―COSMETICS）700 总则GENERAL701 化妆品标识COSMETIC LABELING710 化妆品机构的自愿登记VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS720 化妆品配料构成声明的自愿存档VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS740 化妆品警告声明COSMETIC PRODUCT WARNING STATEMENTS741-799 [预留的] [Reserved]第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES）800 总则GENERAL801 标识LABELING803 医疗器械报告MEDICAL DEVICE REPORTING806 医疗器械；改正与移动的报告MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS807 对器械的制造者与首次进口者的机构登记与器械列表ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES808 对州和地方医疗器械要求的联邦优先权的豁免EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS809 人用体外诊断产品IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE810 医疗器械召回权MEDICAL DEVICE RECALL AUTHORITY812 试验用器械豁免INVESTIGATIONAL DEVICE EXEMPTIONS813 [预留的] [Reserved]814 医疗器械的上市前批准PREMARKET APPROVAL OF MEDICAL DEVICES820 质量体系规章QUALITY SYSTEM REGULATION821 医疗器械跟踪要求MEDICAL DEVICE TRACKING REQUIREMENTS822 上市后监视POSTMARKET SURVEILLANCE860 医疗器械分类程序MEDICAL DEVICE CLASSIFICATION PROCEDURES861 性能标准制定程序PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT862 临床化学与临床毒理学器械CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES864 血液学与病理学器械HEMATOLOGY AND PATHOLOGY DEVICES866 免疫学与微生物学器械IMMUNOLOGY AND MICROBIOLOGY DEVICES868 麻醉学器械ANESTHESIOLOGY DEVICES870 心血管器械CARDIOVASCULAR DEVICES872 牙科器械DENTAL DEVICES874 耳、鼻和咽器械EAR, NOSE, AND THROAT DEVICES876 胃肠病学-泌尿学器械GASTROENTEROLOGY-UROLOGY DEVICES878 普通与整形外科器械GENERAL AND PLASTIC SURGERY DEVICES880 普通医院与个人使用器械GENERAL HOSPITAL AND PERSONAL USE DEVICES882 神经学器械NEUROLOGICAL DEVICES884 产科与妇科学器械OBSTETRICAL AND GYNECOLOGICAL DEVICES886 眼科器械OPHTHALMIC DEVICES888 矫形外科器械ORTHOPEDIC DEVICES890 内科学器械PHYSICAL MEDICINE DEVICES892 放射学器械RADIOLOGY DEVICES895 禁止的器械BANNED DEVICES898 电极铅线与患者电缆的性能标准PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES第I分章―乳房造影质量标准法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDARDS ACT）900 乳房造影法MAMMOGRAPHY第J分章―放射学的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）1000 总则GENERAL1002 记录与报告RECORDS AND REPORTS1003 缺陷与未能守法的通报NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY1004 电子产品的回购、修理或者置换REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS1005 电子产品的进口IMPORTATION OF ELECTRONIC PRODUCTS1010 电子产品的性能标准：总则PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL 1020 电离辐射发生产品的性能标准PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS1030 微波与射电频率发生产品的性能标准PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS1040 发光产品的性能标准PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS1050 声波、次声波和超声波发生产品的性能标准PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS第K分章―[预留的]（SUBCHAPTER K―[RESERVED]）第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）1210 根据《联邦进口乳法》的规章REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT1230 根据《联邦腐蚀性毒物法》的规章REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT1240 传染病的控制CONTROL OF COMMUNICABLE DISEASES1250 州际运输卫生INTERSTATE CONVEYANCE SANITATION1251-1269 [预留的] [Reserved]1270 预期用于移植的人体组织HUMAN TISSUE INTENDED FOR TRANSPLANTATION1271 人体细胞、组织以及细胞的和基于组织的产品HUMAN CELLS, TISSUES, AND CELLULAR ANDTISSUE-BASED PRODUCTS1272-1299 [预留的] [Reserved]第Ⅱ章―司法部毒品强制执行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OFJUSTICE）1300 定义DEFINITIONS1301 管制物质的制造者、分销者和调剂者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES1303 定额QUOTAS1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS1305 令的格式ORDER FORMS1306 处方PRESCRIPTIONS1307 杂项MISCELLANEOUS1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES1309 表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS1310 列入表的化学品和某些机器的记录与报告RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES1311 [预留的] [Reserved]1312 管制物质的进口与出口IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES1313 前体与必要化学品的进口与出口IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS1314-1315 [预留的] [Reserved]1316 行政职能、规范和程序ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES第Ⅲ章―毒品控制政策办公室（CHAPTER Ⅲ―Office of National Drug Control Policy）1400 [预留的] [Reserved]1401 信息的公众可及性PUBLIC AVAILABILITY OF INFORMATION1402 强制性解密审查MANDATORY DECLASSIFICATION REVIEW1403 对给予州和地方政府资金和合作协议的统一行政要求UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS1404 政府范围的排除与暂停（非获得）GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)1405 对无毒品工作场所的政府范围的要求（财政援助）GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)1406-1499 [预留的] [Reserved]。

美国FDA 医疗器械体系法规QSR820中文版Part 820——质量体系法规——目录Subpart A- 总则820.1 范围820.3 定义820.5 质量体系Subpart B –质量体系要求820.20 管理职责820.22 质量审核820.25 人员Subpart C- 设计控制820.30 设计控制Subpart D- 文件控制820.40 文件控制Subpart E- 采购控制820.50 采购控制Subpart F- 标识与可追溯性820.60 标识820.65 可追溯性Subpart G - 生产和过程控制820.70 生产和过程控制820.72 检验、测量和试验设备820.75 过程确认Subpart H - 验收活动:820.80 进货、过程和成品器械检验820.86 检验状态Subpart I –不合格品820.90 不合格品Subpart J - 纠正和预防措施820.100 纠正和预防措施Subpart K –标识和包装控制820.120 设备标签820.130 设备包装Subpart L –搬运/储存/分销和安装820.140 搬运820.150 贮存820.160 分销820.170 安装Subpart L –记录820.180 记录的通用要求820.181 设备主要记录820.184 设备历史记录820.186 质量体系记录820.198 投诉文件Subpart M –服务820.200 服务Subpart N –统计技术820.250 统计技术Subpart A——总则Subpart A--General ProvisionsSec.820.1 范围Sec. 820.1 Scope.（a）适用性Applicability。

（1）本质量体系法规阐明了当前良好制造法规Current good manufacturing practice （CGMP）的要求。

本标准适用于所有预期用于人类的成品器械的设计、制造、包装、标识、储存、安装和服务中所使用的管理方法、设施和控制。

美国FDA 医疗器械体系法规QSR820中文版之南宫帮珍创作Part 820——质量体系法规——目录Subpart A- 总则820.1 范围820.3 界说 820.5 质量体系Subpart B –质量体系要求820.20 管理职责820.22 质量审核 820.25 人员Subpart C- 设计控制 820.30 设计控制Subpart D- 文件控制 820.40 文件控制Subpart E- 推销控制 820.50 推销控制Subpart F- 标识与可追溯性820.60 标识 820.65 可追溯性Subpart G - 生产和过程控制820.70 生产和过程控制820.72 检验、丈量和试验设备 820.75 过程确认Subpart H - 验收活动: 820.80 进货、过程和制品器械检验 820.86 检验状态Subpart I –分歧格品 820.90 分歧格品Subpart J - 纠正和预防办法 820.100 纠正和预防办法Subpart K –标识和包装控制820.120 设备标签 820.130 设备包装Subpart L –搬运/贮存/分销和装置820.140 搬运820.150 贮存820.160 分销 820.170 装置Subpart L –记录820.180 记录的通用要求820.181 设备主要记录820.184 设备历史记录820.186 质量体系记录 820.198 投诉文件Subpart M –服务 820.200 服务Subpart N –统计技术820.250 统计技术Subpart A——总则Subpart A--General Provisions Sec.820.1 范围Sec. 820.1 Scope. （a）适用性Applicability. （1）实质量体系法规说明了以后良好制造法规Current good manufacturing practice（CGMP）的要求.本标准适用于所有预期用于人类的制品器械的设计、制造、包装、标识、贮存、装置和服务中所使用的管理方法、设施和控制.本标准的目的是保证制品器械的平安性和有效性, 并符合联邦食品、药品和化妆品法案Federal Food, Drag and Cosmetic Act （the act）.本法规适用于所有的医疗器械制品制造商.如果制造商仅从事本部份有要求服从的某些过程而未从事其它过程, 则只需符合其实施的过程的要求.对Ⅰ类设备, 设计控制仅适用于Sec.820.30（a）（2）中列出的设备.本法规不适用于制品器械的部件或零件制造商, 但鼓励这类制造商把本法规的适当规定作为指南来使用.人血和血液成份制造商不受本部份法规的限制, 但应遵循本章606部份法规的要求.Current good manufacturing practice(CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensurethat finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to those devices listed in 820.30(a)This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Manufacturers of human blood and blood components are not subject to this part, but are subject to part 606 of this chapter. Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 1271..3(d) of this chapter, that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions of the act or under a biologicalproduct license application under section 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures set forth in part 1271 subpart C of this chapter and applicable current good tissue practice procedures in part 1271 subpart D of this chapter. In the event of a conflict between applicable regulations in part 1271 and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.（2）本部份的规定适用于本部份界说的预期用于人体的所有制品器械, 不论其在美国(包括:美国任何州或领土,哥伦比亚特区,波多黎各联邦)外乡制造还是进口,提供进口的产物.(2) The provisions of this part shall be applicable to any finished device as defined in this part, intended for human use, that is manufactured, imported, or offered for import in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.（3）在本法规中“适用时”（where appropriate）呈现过屡次.当要求根据“where appropriate”被认为是合格时, 其要求应被认为是“适用的”（appropriate）, 除非组织能提供文件证明其理由.如果不执行预期结果会招致产物不符合其特定的要求, 或组织不需要执行任何需要的纠正办法, 那么要求就是适用的（appropriate）.(3) In this regulation the term "where appropriate" is used several times. When a requirement is qualified by "where appropriate," it is deemed to be "appropriate" unless the manufacturer can document justification otherwise. A requirement is "appropriate" if non-implementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.（b）限制.除非特别规定, 则本部份质量体系法规是本章其它部份法规的弥补要求.在不能符合所有适用的法规, 包括本章此部份和其它部份的情况, 特别是对讨论中的设备, 此法规应取代其它通用要求.(b) The quality system regulation in this part supplements regulations in other parts of this chapterexcept where explicitly stated otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.（c）权限.PART820是在（21U.S.C.法令351、352、360、360c、360d、360e、360h、360i、360j、360l、370、374、381、383中）501、502、510、513、514、515、518、519、520、522、701、704、801、803下建立并发布的.不符合本部份（Part 820）的任何适用的规定, 依据法令section 501（h）条款, 可判定该产物为伪劣产物.这类产物及对此不符合负责的任何个人, 将依法被起诉.(c)Authority.Part 820 is established and issued under authority of sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383). The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.（d）外国制造商.如果把器械进口到美国的制造商拒绝允许或同意FDA对其外国工厂履行为确定器械是否符合本法规（Part 820）所进行的检查, 可按section 801（a）条款对其提出诉讼.即准备出口到美国的设备, 其设计、生产、包装、标签、贮存或服务中使用的方法和设备控制不符合本法令section 520（f）和本部份（Part 820）的要求, 可按本法令section 501（h）条款判定在此条件下制造的产物为伪劣产物.(d)Foreign manufacturers.If a manufacturer who offers devices for import into the United States refuses to permit or allow the completion of a Food and Drug Administration (FDA) inspection of the foreign facility for the purpose of determining compliance with this part,it shall appear for purposes of section 801(a) of the act, that the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, or servicing of any devices produced at such facility that are offered for import into the United States do not conform to the requirements of section 520(f) of the act and this part and that the devices manufactured at that facility are adulterated under section 501(h) of the act.（e）豁免或特别许可/Exemptions or variances （1）任何人希望得就任何医疗器械质量体系要求的豁免或特别许可, 应符合法令section 520（f）（2）的要求.根据本章Sec.10.30即FDA行政法式, 来提交豁免或特别许可的申请.可以从器械和辐射健康中心和小型制造商援助处获得指导, 地址（HFZ-220）, 1350 Piccard Dr., Rockville, MD20850, U.S.A., 德律风1-800-638-2041或1-301-443-6597, 传真301-443-8818. (1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in 10.30 of this chapter, the FDA's administrative procedures. Guidance is available from the Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD20850, U.S.A., telephone 1-800-638-2041 or 240-276-3150, FAX 240-276-3151.（2）在有关部份确定此种改变符合美国公众健康的最佳利益时, FDA可能发起并同意器械质量体系的特别许可.公在美国公众健康确实需要该设备, 且如无此特别许可, 则器械就不成能充沛有效的生产的情况下, 特别许可才有效.(2) FDA may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best interest of the public health. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.（f）本部份不适用于本章897部份界说的烟草销售商.Sec.820.3 界说/ Definitions （a）法案Act.指明Federal Food, Drug and Cosmetic Act, 如修正的（secs.201-903, 52 Stat. 1040 et sep., 21 U.S.C. 321-394）.所有法案section 201中的界说在本部份法规中均适用.(a)Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs. 201-903, 52 Stat. 1040et seq., as amended (21 U.S.C. 321-394)). All definitions in section 201 of the act shall apply to the regulations in this part.（b）投诉Complaint.在设备交付后所有的书面的、电子的或口头的, 对设备的标识、质量、耐用性、可靠性、平安性、有效性和性能方面缺陷的信息.(b)Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.（c）部件Component.所有意图用来包括成为已完成的、包装、标识的器械的一部份的原资料、物资、构件、零件、软件、固件、连接件、标签或它们的集合.(c)Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.（d）控制号Control number.任何鉴别性符号, 如由字母、数字或它们的组合形成的唯一性组合, 由控制号可以确定一批或一个器械的制造、包装、标识和交付的历史.(d)Control number means any distinctive symbols, such as a distinctive combination of letters or numbers, or both,from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined.（e）设计历史文件Design history file（DHF）.制品器械的设计历史记录的汇总.(e)Design history file(DHF) means a compilation of records which describes the design history of a finished device.（f）设计输入Design input.器械实体和性能要求, 是产物设计的基础.(f)Design input means the physical and performance requirements of a device that are used as a basis for device design.（g）设计输出Design output.是指每个设计阶段和最后所有的设计功效的结果.已完成的设计输出是器械主记录的基础.全部最终完成的设计输出, 由器械及其包装和标识和设备主记录组成. (g)Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for thedevice master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.（h）设计评审Design review.是指对设计的一个文件化的、全面的、系统的检查, 评价其满足设计要求, 评价其有能力满足要求, 并识别任何问题.(h)Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.（i）设备历史记录Device history record（DHR）.制品器械历史记录的汇总.(i)Device history record(DHR) means a compilation of records containing the production history of a finished device.（j） Device master record（DMR）.制品器械的法式和规范的汇总.(j)Device master record(DMR) means a compilation ofrecords containing the procedures and specifications for a finished device.（k）建立Establish.界说文件（书面或电子的）并执行.(k)Establish means define, document (in writing or electronically), and implement.（l）制品器械Finished device.设备或其附件, 无论其是否包装、标识或灭菌, 能够满足使用要求或者说能够实现其功能.(l)Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.（m） Lot或batch.一个或多个元件或制品器械, 均为同一种规格、型号、尺寸、成份或软件版本, 在相同条件下生产, 满足相同的特性和质量要求.(m)Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.（n）执行职责的管理者Management with executive responsibility.是组织的高级员工, 他们负有建立或更改组织的质量方针和质量体系的职权.(n)Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.（o）制造商/组织Manufacturer.是指设计、制造、制作（fabricate）、装配或加工制品器械的任何人.制造商包括但不单限于根据合同执行灭菌、装置、重新标识、重新制造、重新包装或特定的开发职责的制造商, 和执行这些职责的国外组织的国内分销商.(o)Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.（p） Manufacturing material.指任何用于或用于催化制造过程的任何原料或物质, 在制造过程中发生的陪伴的成份或副产物, 其在制品器械中/上呈现为残留物或杂质, 它不是制造商的设计或意图.(p)Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.（q）分歧格Nonconformity.未满足规定的要求.(q)Nonconformity means the nonfulfillment of a specified requirement.（r）产物Product.部件、原资料、在制品、制品和返回品. (r)Product means components, manufacturing materials, in- process devices, finished devices, and returned devices.（s）质量Quality.一组固有特性满足要求的法式, 包括平安和性能.(s)Quality means the totality of features andcharacteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.（t）质量审核Quality Audit.按规定的时间间隙和频率, 对制造商的质量体系进行系统、客观的检查, 以确定质量体系活动及其结果符合质量体系法式, 这些法式获得有效执行, 法式适应质量目标的需求.(t)Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.（u）质量方针Quality policy.由制造商的最高管理者发布的组织总的质量宗旨和方向.(u)Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.（v）质量体系Quality system.质量管理的组织结构、职责、法式、过程和资源.(v)Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.（w） Remanufacturer.指对制品器械进行处理、修整、修复、重新包装、恢复或其它活动的人, 使制品器械的性能、平安规范或预期用途发生重年夜更改.(w)Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.（x）返工Rework.为使分歧格品在其交付前符合DMR的要求而采用的办法.(x)Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.（y）规范Specification.产物、过程、服务或其它活动应符合的要求.(y)Specification means any requirement with which a product, process, service, or other activity must conform.（z）确认Validation.通过检查和提供客观证据证明满足预期用途的要求.(z)Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.（1）过程确认Process validation.根据客观证据确定过程可继续发生满足预先确定例范的结果或产物.(1)Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.（2）设计确认Design validation.根据客观证据确定设备规范符合使用者的需求和预期用途.(2)Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).（aa）验证Verification.通过检查和提供客观证据证明满足规定的要求.(aa)Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.Sec.820.5 质量体系/ Quality system. 制造商应建立并实施适应特定的医疗器械设计或制造, 并符合本部份要求的质量体系.Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.Subpart B——质量体系要求/Quality System Requirements Sec.820.20 管理职责/Management responsibility （a）质量方针：负有执行职责的管理者应建立质量方针和目标以及在质量方面的许诺, 应保证组织内所有级别都能正确理解并执行质量方针.(a)Quality policy.Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the qualitypolicy is understood, implemented, and maintained at all levels of the organization.（b）组织：建立并坚持适宜的组织结构, 确保产物的设计和生产符合本部份（Part 820）的要求.(b)Organization.Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.（1）职责和权限.制造商应明确影响质量的管理、把持和评价人员的职责、权限及相互关系, 为其提供执行这些工作必需的自主权和权限.(1)Responsibility and authority.Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.（2）资源.制造商应提供适当的资源, 包括由经过培训的人员, 执行管理、把持和包括内部质量审核在内的活动, 以符合本部份（Part 820）的要求.2)Resources.Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.（3）管理者代表.最高管理者应在管理层中以书面方式指定一名管理者代表, 无论其在其它方面的职责如何, 应具有以下方面的职责和权限：(3)Management representative.Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:（i）确保根据本部份（Part 820）的要求有效地建立、实施和坚持质量管理体系；(i) Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and（ii）向负有执行职责的管理者陈说质量体系运行情况, 以供评审.(ii) Reporting on the performance of the quality system to management with executive responsibility for review.（c）管理评审.负有执行职责的管理者, 应按法式规定的时间间隔对证量体系进行审核.确保质量体系的继续适宜性和有效性, 以满足本标准的要求和组织规定的质量方针和目标.评审的日期和结果应形成文件并记录.(c)Management review.Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.（d）质量规画.制造商应建立质量规画, 确定设计和制造设备所需的质量准则、资源和活动, 形成质量计划.组织应确定如何满足质量要求.(d)Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that aredesigned and manufactured. The manufacturer shall establish how the requirements for quality will be met.（e）质量体系法式.制造商应建立质量体系法式和规范, 适用时应建立质量体系的文件化的结构描述.(e)Quality system procedures.Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate. Sec.820.22 质量审核Quality audit.制造商应建立并实施质量审核法式和活动, 以确保质量体系符合既定的质量体系要求, 确定质量体系的有效性.质量审核应由与所审核的活动无直接责任的人员进行.纠正办法, 需要时包括对不符合项的重新审核.每次质量审核和重新审核的结果应形成陈说, 陈说要经对审核负有责任的管理者评审.审核和重新审核的日期和结果应予记录.Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted byindividuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.Sec.820.25 人员/Personnel （a）概述.制造商应有足够的人员, 经过需要的教育、工作布景、专业培训和相关的经验, 以保证所有法规要求的活动能够获得正确的执行.(a)General.Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.（b）培训.制造商应建立培训的文件, 明确培训需求, 保证所有人员都能得充沛的培训, 以保证满足工作的要求.培训应形成记录.(b)Training. Each manufacturer shall establish proceduresfor identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.（1）作为培训的一部份, 应使员工意识到他们的特殊工作中的不正确的把持可造成设备的缺陷.(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.（2）负有验证和确认职责的人员应意识到, 在其工作中会遇到缺陷和毛病.(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.(1) Each manufacturer of any class III or class II device,and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.(2) The following class I devices are subject to design controls:(i) Devices automated with computer software; and(ii) The devices listed in the following chart.Device868.6810 导管、呼吸机878.4460 手套、外科医生用手套880.6760 阻止、呵护用品892.5650 生化、涂药器、放射性、手工制造（Manual）892.5740 源、放射治疗（b）设计和开发规画.组织应建立并实施设计和开发计划, 其内容描述或包括了设计和开发的相关活动并界说了执行的职责.计划应明确并描述分歧部份/组间的接口及活动, 其结果是设计输入和开发过程.计划应随着设计和开发的推进进行评审、更新, 并经批准.(b)Design and development planning.Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.（c）设计输入.组织应建立并坚持法式, 以保证与产物相关的设计要求是适宜的, 并满足设备的预期用途, 包括使用者和患者的需要.这个法式应包括解决任何不完全、不明确和相互矛盾的要求的机制.设计输入要求应经审核, 并经指定的人员审核和批准.审批应包括审批人员的签名和日期, 审批应予记录.(c)Design input.Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.（d）设计输出.组织应建立并坚持文件化的设计输出法式, 使经过评审的设计输出文件满足设计输入的要求.设计输出法式应包括或涉及接收标准, 确保实现设备基本的、适用的功能.设计输出应是文件化的, 在发布前应经评审和批准.审批应文件化, 包括批准人的签名及日期.(d)Design output.Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented.（e）设计评审.组织应建立并实施法式, 确保在产物设计开发的适当阶段, 有计划地对设计结果进行正式的评审.法式应确保每次设计评审的介入者, 应包括与被评审的设计阶段有关的所有职能部份的代表, 和一名或多名与被评审设计阶段无直接责任的人员, 需要时也可包括其它专家.评审结果, 包括设计标识（identification of design）、日期、评审的人员, 应在设计历史文件中予以记录.(e)Design review.Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conductedat appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).（f）设计验证.组织应建立并实施设计验证的法式.确保设计输出满足设计输入的要求.设计验证的结果, 包括设计标识（identification of design）、方法、日期、验证的人员, 应在设计历史文件中予以记录.(f)Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in theDHF.（g）设计确认.组织应建立并实施设计确认法式.设计确认应在规定的把持条件下, 对最初的产物、批次或其等价物上进行.设计确认应确保产物满足规定的用户需求和预期的使用要求, 也包括在实际或模拟的使用条件下对产物单位进行试验.适用时, 设计确认应包括软件确认和风险分析.设计确认的结果, 包括设计标识（identification of design）、方法、日期、确认的人员, 应在设计历史文件中予以记录.(g)Design validation.Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.（h）设计转换.组织应建立并坚持文件化的法式, 以保证产物的设计能够正确的转换成产物的规范.(h)Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.（i）设计更改.组织应建立并坚持法式, 在执行前设计更改应被识别、文件化、确认或适用时经验证、评审和批准.(i)Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.（j）设计历史文件.组织应建立并坚持每个型号的产物的DHF.DHF应包括或涉及需要的记录, 以证明设计的进程符合被批准的设计计划和本部份的要求.(j)Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.Subpart D——文件控制Document ControlsSec.820.40 文件控制Document Controls 组织应建立并实施法式, 以控制所有本部份要求的文件.法式应包括：Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:（a）文件的批准和发布.所有文件在发布前应由授权人员评审、批准其适宜性, 以满足本部份的要求.文件的批准, 包括批准发布人员的签名及日期应形成记录.确保在文件适用的场所能够获得相关文件, 从所有发放或使用场所及时撤出作废文件, 以防止作废文件的非预期使用.(a)Document approval and distribution.Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all。

TITLE21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER H--MEDICAL DEVICESPART820QUALITY SYSTEM REGULATIONSubpart A--General ProvisionsSec.820.1Scope.(a)Applicability.(1)Current good manufacturing practice(CGMP)requirements are set forth in this quality system regulation.The requirements in this part govern the methods used in,and the facilities and controls used for,the design, manufacture,packaging,labeling,storage,installation,and servicing of all finished devices intended for human use.The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food,Drug,and Cosmetic Act(the act).This part establishes basic requirements applicable to manufacturers of finished medical devices.If a manufacturer engages in only some operations subject to the requirements in this part,and not in others,that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.With respect to class I devices,design controls apply only to those devices listed in820.30(a)(2). This regulation does not apply to manufacturers of components or parts of finished devices,but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance.Manufacturers of blood and blood components used for transfusion or for further manufacturing are not subject to this part,but are subject to subchapter F of this chapter.Manufacturers of human cells,tissues,and cellular and tissue-based products(HCT/Ps),as defined in1271.3(d)of this chapter,that are medical devices(subject to premarket review or notification,or exempt from notification,under an application submitted under the device provisions of the act or under a biological product license application under section351of the Public Health Service Act)are subject to this part and are also subject to the donor-eligibility procedures set forth in part1271subpart C of this chapter and applicable current good tissue practice procedures in part1271subpart D of this chapter.In the event of a conflict between applicable regulations in part1271and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.(2)The provisions of this part shall be applicable to any finished device as defined in this part,intended for human use, that is manufactured,imported,or offered for import in any State or Territory of the United States,the District of Columbia, or the Commonwealth of Puerto Rico.(3)In this regulation the term"where appropriate"is used several times.When a requirement is qualified by"where appropriate,"it is deemed to be"appropriate"unless the manufacturer can document justification otherwise.A requirement is"appropriate"if nonimplementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.(b)The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise.In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.(c)Authority.Part820is established and issued under authority of sections501,502,510,513,514,515,518,519,520, 522,701,704,801,803of the act(21U.S.C.351,352,360,360c,360d,360e,360h,360i,360j,360l,371,374,381,383). The failure to comply with any applicable provision in this part renders a device adulterated under section501(h)of the act. Such a device,as well as any person responsible for the failure to comply,is subject to regulatory action.(d)Foreign manufacturers.If a manufacturer who offers devices for import into the United States refuses to permit orallow the completion of a Food and Drug Administration(FDA)inspection of the foreign facility for the purpose of determining compliance with this part,it shall appear for purposes of section801(a)of the act,that the methods used in, and the facilities and controls used for,the design,manufacture,packaging,labeling,storage,installation,or servicing of any devices produced at such facility that are offered for import into the United States do not conform to the requirements of section520(f)of the act and this part and that the devices manufactured at that facility are adulterated under section 501(h)of the act.(e)Exemptions or variances.(1)Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section520(f)(2)of the act.Petitions for an exemption or variance shall be submitted according to the procedures set forth in10.30of this chapter,the FDA's administrative procedures. Guidance is available from the Food and Drug Administration,Center for Devices and Radiological Health,Division of Small Manufacturers,International and Consumer Assistance,10903New Hampshire Ave.,Bldg.66,rm.4613,Silver Spring,MD 20993-0002,1-800-638-2041or301-796-7100,FAX:301-847-8149.(2)FDA may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best interest of the public health.Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.[61FR52654,Oct.7,1996,as amended at65FR17136,Mar.31,2000;65FR66636,Nov.7,2000;69FR29829,May25, 2005;72FR17399,Apr.9,2007;75FR20915,Apr.22,2010;80FR29906,May22,2015]Sec.820.3Definitions.(a)Act means the Federal Food,Drug,and Cosmetic Act,as amended(secs.201-903,52Stat.1040et seq.,as amended(21 U.S.C.321-394)).All definitions in section201of the act shall apply to the regulations in this part.(b)Complaint means any written,electronic,or oral communication that alleges deficiencies related to the identity,quality, durability,reliability,safety,effectiveness,or performance of a device after it is released for distribution.(c)Component means any raw material,substance,piece,part,software,firmware,labeling,or assembly which is intended to be included as part of the finished,packaged,and labeled device.(d)Control number means any distinctive symbols,such as a distinctive combination of letters or numbers,or both,from which the history of the manufacturing,packaging,labeling,and distribution of a unit,lot,or batch of finished devices can be determined.(e)Design history file(DHF)means a compilation of records which describes the design history of a finished device.(f)Design input means the physical and performance requirements of a device that are used as a basis for device design.(g)Design output means the results of a design effort at each design phase and at the end of the total design effort.The finished design output is the basis for the device master record.The total finished design output consists of the device,its packaging and labeling,and the device master record.(h)Design review means a documented,comprehensive,systematic examination of a design to evaluate the adequacy of the design requirements,to evaluate the capability of the design to meet these requirements,and to identify problems. (i)Device history record(DHR)means a compilation of records containing the production history of a finished device. (j)Device master record(DMR)means a compilation of records containing the procedures and specifications for a finisheddevice.(k)Establish means define,document(in writing or electronically),and implement.(l)Finished device means any device or accessory to any device that is suitable for use or capable of functioning,whether or not it is packaged,labeled,or sterilized.(m)Lot or batch means one or more components or finished devices that consist of a single type,model,class,size, composition,or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.(n)Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.(o)Manufacturer means any person who designs,manufactures,fabricates,assembles,or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization,installation, relabeling,remanufacturing,repacking,or specification development,and initial distributors of foreign entities performing these functions.(p)Manufacturing material means any material or substance used in or used to facilitate the manufacturing process,a concomitant constituent,or a byproduct constituent produced during the manufacturing process,which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.(q)Nonconformity means the nonfulfillment of a specified requirement.(r)Product means components,manufacturing materials,in-process devices,finished devices,and returned devices.(s)Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.(t)Quality audit means a systematic,independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures,that these procedures are implemented effectively,and that these procedures are suitable to achieve quality system objectives.(u)Quality policy means the overall intentions and direction of an organization with respect to quality,as established by management with executive responsibility.(v)Quality system means the organizational structure,responsibilities,procedures,processes,and resources for implementing quality management.(w)Remanufacturer means any person who processes,conditions,renovates,repackages,restores,or does any other act to a finished device that significantly changes the finished device's performance or safety specifications,or intended use.(x)Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.(y)Specification means any requirement with which a product,process,service,or other activity must conform.(z)Validation means confirmation by examination and provision of objective evidence that the particular requirements fora specific intended use can be consistently fulfilled.(1)Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.(2)Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).(aa)Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.(bb)Human cell,tissue,or cellular or tissue-based product(HCT/P)regulated as a device means an HCT/P as defined in 1271.3(d)of this chapter that does not meet the criteria in1271.10(a)and that is also regulated as a device.(cc)Unique device identifier(UDI)means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of830.20of this chapter.A unique device identifier is composed of:(1)A device identifier--a mandatory,fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device;and(2)A production identifier--a conditional,variable portion of a UDI that identifies one or more of the following when included on the label of the device:(i)The lot or batch within which a device was manufactured;(ii)The serial number of a specific device;(iii)The expiration date of a specific device;(iv)The date a specific device was manufactured.(v)For an HCT/P regulated as a device,the distinct identification code required by1271.290(c)of this chapter.(dd)Universal product code(UPC)means the product identifier used to identify an item sold at retail in the United States. [61FR52654,Oct.7,1996,as amended at78FR58822,Sept.24,2013]Sec.820.5Quality system.Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured,and that meets the requirements of this part.Subpart B--Quality System RequirementsSec.820.20Management responsibility.(a)Quality policy.Management with executive responsibility shall establish its policy and objectives for,and commitment to,quality.Management with executive responsibility shall ensure that the quality policy is understood,implemented,and maintained at all levels of the organization.(b)Organization.Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.(1)Responsibility and authority.Each manufacturer shall establish the appropriate responsibility,authority,and interrelation of all personnel who manage,perform,and assess work affecting quality,and provide the independence and authority necessary to perform these tasks.(2)Resources.Each manufacturer shall provide adequate resources,including the assignment of trained personnel,for management,performance of work,and assessment activities,including internal quality audits,to meet the requirements of this part.(3)Management representative.Management with executive responsibility shall appoint,and document such appointment of,a member of management who,irrespective of other responsibilities,shall have established authority over and responsibility for:(i)Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part;and(ii)Reporting on the performance of the quality system to management with executive responsibility for review.(c)Management review.Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives.The dates and results of quality system reviews shall be documented.(d)Quality planning.Each manufacturer shall establish a quality plan which defines the quality practices,resources,and activities relevant to devices that are designed and manufactured.The manufacturer shall establish how the requirements for quality will be met.(e)Quality system procedures.Each manufacturer shall establish quality system procedures and instructions.An outline of the structure of the documentation used in the quality system shall be established where appropriate.Sec.820.22Quality audit.Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s),including a reaudit of deficient matters,shall be taken when necessary.A report of the results of each quality audit,and reaudit(s)where taken,shall be made and such reports shall be reviewed by management having responsibility for the matters audited.The dates and results of quality audits and reaudits shall be documented.Sec.820.25Personnel.(a)General.Each manufacturer shall have sufficient personnel with the necessary education,background,training,and experience to assure that all activities required by this part are correctly performed.(b)Training.Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.Training shall be documented.(1)As part of their training,personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.(2)Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.Subpart C--Design ControlsSec.820.30Design controls.(a)General.(1)Each manufacturer of any class III or class II device,and the class I devices listed in paragraph(a)(2)of this section,shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.(2)The following class I devices are subject to design controls:(i)Devices automated with computer software;and(ii)The devices listed in the following chart.Section Device868.6810Catheter,Tracheobronchial Suction.878.4460Glove,Surgeon's.880.6760Restraint,Protective.892.5650System,Applicator,Radionuclide,Manual.892.5740Source,Radionuclide Teletherapy.(b)Design and development planning.Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation.The plans shall identify and describe the interfaces with different groups or activities that provide,or result in,input to the design and development process.The plans shall be reviewed,updated,and approved as design and development evolves.(c)Design input.Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device,including the needs of the user and patient.The procedures shall include a mechanism for addressing incomplete,ambiguous,or conflicting requirements.The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s).The approval,including the date and signature of the individual(s)approving the requirements,shall be documented.(d)Design output.Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements.Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified.Design output shall be documented,reviewed,and approved before release.The approval,including the date and signature of the individual(s)approving the output,shall be documented. (e)Design review.Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development.The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s)who does not have direct responsibility for the design stage being reviewed,as well as any specialists needed.The results of a design review,including identification of the design,the date,and the individual(s)performing the review,shall be documented in the design history file(the DHF).(f)Design verification.Each manufacturer shall establish and maintain procedures for verifying the device design.Design verification shall confirm that the design output meets the design input requirements.The results of the design verification,including identification of the design,method(s),the date,and the individual(s)performing the verification,shall be documented in the DHF.(g)Design validation.Each manufacturer shall establish and maintain procedures for validating the device design.Design validation shall be performed under defined operating conditions on initial production units,lots,or batches,or their equivalents.Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.Design validation shall include software validation and risk analysis,where appropriate.The results of the design validation,including identification of the design,method(s), the date,and the individual(s)performing the validation,shall be documented in the DHF.(h)Design transfer.Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.(i)Design changes.Each manufacturer shall establish and maintain procedures for the identification,documentation, validation or where appropriate verification,review,and approval of design changes before their implementation.(j)Design history file.Each manufacturer shall establish and maintain a DHF for each type of device.The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.Subpart D--Document ControlsSec.820.40Document controls.Each manufacturer shall establish and maintain procedures to control all documents that are required by this part.The procedures shall provide for the following:(a)Document approval and distribution.Each manufacturer shall designate an individual(s)to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part.The approval,including the date and signature of the individual(s)approving the document,shall be documented.Documents established to meet the requirements of this part shall be available at all locations for which they are designated,used,or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.(b)Document changes.Changes to documents shall be reviewed and approved by an individual(s)in the same function or organization that performed the original review and approval,unless specifically designated otherwise.Approved changes shall be communicated to the appropriate personnel in a timely manner.Each manufacturer shall maintain records of changes to documents.Change records shall include a description of the change,identification of the affected documents, the signature of the approving individual(s),the approval date,and when the change becomes effective.Subpart E--Purchasing ControlsSec.820.50Purchasing controls.Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.(a)Evaluation of suppliers,contractors,and consultants.Each manufacturer shall establish and maintain the requirements, including quality requirements,that must be met by suppliers,contractors,and consultants.Each manufacturer shall: (1)Evaluate and select potential suppliers,contractors,and consultants on the basis of their ability to meet specifiedrequirements,including quality requirements.The evaluation shall be documented.(2)Define the type and extent of control to be exercised over the product,services,suppliers,contractors,and consultants, based on the evaluation results.(3)Establish and maintain records of acceptable suppliers,contractors,and consultants.(b)Purchasing data.Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements,including quality requirements,for purchased or otherwise received product and services.Purchasing documents shall include,where possible,an agreement that the suppliers,contractors,and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device.Purchasing data shall be approved in accordance with820.40.Subpart F--Identification and TraceabilitySec.820.60Identification.Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt,production, distribution,and installation to prevent mixups.Sec.820.65Traceability.Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit,lot,or batch of finished devices and where appropriate components.The procedures shall facilitate corrective action.Such identification shall be documented in the DHR.Subpart G--Production and Process ControlsSec.820.70Production and process controls.(a)General.Each manufacturer shall develop,conduct,control,and monitor production processes to ensure that a device conforms to its specifications.Where deviations from device specifications could occur as a result of the manufacturing process,the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.Where process controls are needed they shall include:(1)Documented instructions,standard operating procedures(SOP's),and methods that define and control the manner of production;(2)Monitoring and control of process parameters and component and device characteristics during production;(3)Compliance with specified reference standards or codes;(4)The approval of processes and process equipment;and(5)Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.(b)Production and process changes.Each manufacturer shall establish and maintain procedures for changes to a specification,method,process,or procedure.Such changes shall be verified or where appropriate validated according to 820.75,before implementation and these activities shall be documented.Changes shall be approved in accordance with820.40.(c)Environmental control.Where environmental conditions could reasonably be expected to have an adverse effect on product quality,the manufacturer shall establish and maintain procedures to adequately control these environmental conditions.Environmental control system(s)shall be periodically inspected to verify that the system,including necessary equipment,is adequate and functioning properly.These activities shall be documented and reviewed.(d)Personnel.Each manufacturer shall establish and maintain requirements for the health,cleanliness,personal practices, and clothing of personnel if contact between such personnel and product or environment could reasonably be expected to have an adverse effect on product quality.The manufacturer shall ensure that maintenance and other personnel who are required to work temporarily under special environmental conditions are appropriately trained or supervised by a trained individual.(e)Contamination control.Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.(f)Buildings.Buildings shall be of suitable design and contain sufficient space to perform necessary operations,prevent mixups,and assure orderly handling.(g)Equipment.Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed,constructed,placed,and installed to facilitate maintenance,adjustment, cleaning,and use.(1)Maintenance schedule.Each manufacturer shall establish and maintain schedules for the adjustment,cleaning,and other maintenance of equipment to ensure that manufacturing specifications are met.Maintenance activities,including the date and individual(s)performing the maintenance activities,shall be documented.(2)Inspection.Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules.The inspections,including the date and individual(s) conducting the inspections,shall be documented.(3)Adjustment.Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments. (h)Manufacturing material.Where a manufacturing material could reasonably be expected to have an adverse effect on product quality,the manufacturer shall establish and maintain procedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device's quality.The removal or reduction of such manufacturing material shall be documented.(i)Automated processes.When computers or automated data processing systems are used as part of production or the quality system,the manufacturer shall validate computer software for its intended use according to an established protocol.All software changes shall be validated before approval and issuance.These validation activities and results shall be documented.Sec.820.72Inspection,measuring,and test equipment.(a)Control of inspection,measuring,and test equipment.Each manufacturer shall ensure that all inspection,measuring, and test equipment,including mechanical,automated,or electronic inspection and test equipment,is suitable for its intended purposes and is capable of producing valid results.Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated,inspected,checked,and maintained.The procedures shall include provisions。

SUBCHAPTER H--MEDICAL DEVICESPART 820 QUALITY SYSTEM REGULATION Subpart A--General Provisions§ 820.1 - Scope.§ 820.3 - Definitions.§ 820.5 - Quality system.Subpart B--Quality System Requirements§ 820.20 - Management responsibility.§ 820.22 - Quality audit.§ 820.25 - Personnel.Subpart C--Design Controls§ 820.30 - Design controls.Subpart D--Document Controls§ 820.40 - Document controls.Subpart E--Purchasing Controls§ 820.50 - Purchasing controls.Subpart F--Identification and Traceability§ 820.60 - Identification.§ 820.65 - Traceability.Subpart G--Production and Process Controls§ 820.70 - Production and process controls.§ 820.72 - Inspection, measuring, and test equipment.§ 820.75 - Process validation.Subpart H--Acceptance Activities§ 820.80 - Receiving, in-process, and finished device acceptance. § 820.86 - Acceptance status.Subpart I--Nonconforming Product§ 820.90 - Nonconforming product.Subpart J--Corrective and Preventive Action§ 820.100 - Corrective and preventive action.Subpart K--Labeling and Packaging Control§ 820.120 - Device labeling.§ 820.130 - Device packaging.Subpart L--Handling, Storage, Distribution, and Installation§ 820.140 - Handling.§ 820.150 - Storage.§ 820.160 - Distribution.§ 820.170 - Installation.Subpart M--Records§ 820.180 - General requirements.§ 820.181 - Device master record.§ 820.184 - Device history record.§ 820.186 - Quality system record.§ 820.198 - Complaint files.Subpart N--Servicing§ 820.200 - Servicing.Subpart O--Statistical Techniques§ 820.250 - Statistical techniques.Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.Source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.Subpart A--General ProvisionsSec. 820.1 Scope.(a)Applicability. (1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged. With respect to class I devices, design controls apply only to those devices listed in 820.30(a)(2). This regulation does not apply to manufacturers of components or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Manufacturers of humanblood and blood components are not subject to this part, but are subject to part 606 of this chapter. Manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 1271.3(d) of this chapter, that are medical devices (subject to premarket review or notification, or exempt from notification, under an application submitted under the device provisions of the act or under a biological product license application under section 351 of the Public Health Service Act) are subject to this part and are also subject to the donor-eligibility procedures set forth in part 1271 subpart C of this chapter and applicable current good tissue practice procedures in part 1271 subpart D of this chapter. In the event of a conflict between applicable regulations in part 1271 and in other parts of this chapter, the regulation specifically applicable to the device in question shall supersede the more general.(2) The provisions of this part shall be applicable to any finished device as defined in this part, intended for human use, that is manufactured, imported, or offered for import in any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.(3) In this regulation the term "where appropriate" is used several times. When a requirement is qualified by "where appropriate," it is deemed to be "appropriate" unless the manufacturer can document justification otherwise. A requirement is "appropriate" if nonimplementation could reasonably be expected to result in the product not meeting its specified requirements or the manufacturer not being able to carry out any necessary corrective action.(b) The quality system regulation in this part supplements regulations in other parts of this chapter except where explicitly stated otherwise. In the event of a conflict between applicable regulations in this part and in other parts of this chapter, the regulations specifically applicable to the device in question shall supersede any other generally applicable requirements.(c)Authority. Part 820 is established and issued under authority of sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the act (21U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383). The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.(d)Foreign manufacturers. If a manufacturer who offers devices for import into the United States refuses to permit or allow the completion of a Food and Drug Administration (FDA) inspection of the foreign facility for the purpose of determining compliance with this part, it shall appear for purposes of section 801(a) of the act, that the methods used in, and the facilities and controls usedfor, the design, manufacture, packaging, labeling, storage, installation, or servicing of any devices produced at such facility that are offered for import into the United States do not conform to the requirements of section 520(f) of the act and this part and that the devices manufactured at that facility are adulterated under section 501(h) of the act.(e)Exemptions or variances . (1) Any person who wishes to petition for an exemption or variance from any device quality system requirement is subject to the requirements of section 520(f)(2) of the act. Petitions for an exemption or variance shall be submitted according to the procedures set forth in 10.30 of this chapter, the FDA's administrative procedures. Guidance is available from the Center for Devices and Radiological Health, Division of Small Manufacturers, International and Consumer Assistance (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A., telephone 1-800-638-2041 or 240-276-3150, FAX 240-276-3151.(2) FDA may initiate and grant a variance from any device quality system requirement when the agency determines that such variance is in the best interest of the public health. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance.[61 FR 52654, Oct. 7, 1996, as amended at 65 FR 17136, Mar. 31, 2000; 65 FR 66636, Nov. 7, 2000; 69 FR 29829, May 25, 2005; 72 FR 17399, Apr. 9, 2007] Sec. 820.3 Definitions.(a)Act means the Federal Food, Drug, and Cosmetic Act, as amended (secs.201-903, 52 Stat. 1040et seq., as amended (21 U.S.C. 321-394)). All definitions in section 201 of the act shall apply to the regulations in this part.(b)Complaint means any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution. (c)Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.(d)Control number means any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined.(e)Design history file (DHF ) means a compilation of records which describes the design history of a finished device.(f)Design input means the physical and performance requirements of a device that are used as a basis for device design.(g)Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record.(h)Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.(i)Device history record (DHR ) means a compilation of records containing the production history of a finished device.(j)Device master record (DMR ) means a compilation of records containing the procedures and specifications for a finished device.(k)Establish means define, document (in writing or electronically), and implement.(l)Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized. (m)Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.(n)Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.(o)Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.(p)Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or onthe finished device as a residue or impurity not by design or intent of the manufacturer.(q)Nonconformity means the nonfulfillment of a specified requirement.(r)Product means components, manufacturing materials, in- process devices, finished devices, and returned devices.(s)Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.(t)Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.(u)Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.(v)Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. (w)Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.(x)Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.(y)Specification means any requirement with which a product, process, service, or other activity must conform.(z)Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.(1)Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.(2)Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).(aa)Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.Sec. 820.5 Quality system.Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part.Subpart B--Quality System RequirementsSec. 820.20 Management responsibility.(a)Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.(b)Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.(1)Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.(2)Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of this part.(3)Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:(i) Ensuring that quality system requirements are effectively established andeffectively maintained in accordance with this part; and(ii) Reporting on the performance of the quality system to management with executive responsibility for review.(c)Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.(d)Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.(e)Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate.Sec. 820.22 Quality audit.Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including a reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented. Sec. 820.25 Personnel.(a)General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.(b)Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform theirassigned responsibilities. Training shall be documented.(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs. (2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.(d)Design output. Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented.(e)Design review. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).(f)Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.(g)Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.(h)Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.(i)Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.(j)Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.Subpart D--Document ControlsSec. 820.40 Document controls.Each manufacturer shall establish and maintain procedures to control all documents that are required by this part. The procedures shall provide for the following:(a)Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.(b)Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.Subpart E--Purchasing ControlsSec. 820.50 Purchasing controls.Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.(a)Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.(b)Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with 820.40.Subpart F--Identification and TraceabilitySec. 820.60 Identification.Each manufacturer shall establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups.Sec. 820.65 Traceability.Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used inaccordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR. Subpart G--Production and Process ControlsSec. 820.70 Production and process controls.(a)General. Each manufacturer shall develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications. Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications. Where process controls are needed they shall include:(1) Documented instructions, standard operating procedures (SOP's), and methods that define and control the manner of production;(2) Monitoring and control of process parameters and component and device characteristics during production;(3) Compliance with specified reference standards or codes;(4) The approval of processes and process equipment; and(5) Criteria for workmanship which shall be expressed in documented standards or by means of identified and approved representative samples.(b)Production and process changes. Each manufacturer shall establish and maintain procedures for changes to a specification, method, process, or procedure. Such changes shall be verified or where appropriate validated according to 820.75, before implementation and these activities shall be documented. Changes shall be approved in accordance with 820.40.(c)Environmental control. Where environmental conditions could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures to adequately control these environmental conditions. Environmental control system(s) shall be periodically inspected toverify that the system, including necessary equipment, is adequate and functioning properly. These activities shall be documented and reviewed.(d)Personnel. Each manufacturer shall establish and maintain requirements for the health, cleanliness, personal practices, and clothing of personnel if contact between such personnel and product or environment could reasonably be expected to have an adverse effect on product quality. The manufacturer shall ensure that maintenance and other personnel who are required to work temporarily under special environmental conditions are appropriately trained or supervised by a trained individual.(e)Contamination control. Each manufacturer shall establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality.(f)Buildings. Buildings shall be of suitable design and contain sufficient space to perform necessary operations, prevent mixups, and assure orderly handling.(g)Equipment. Each manufacturer shall ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use.(1)Maintenance schedule. Each manufacturer shall establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met. Maintenance activities, including the date and individual(s) performing the maintenance activities, shall be documented.(2)Inspection. Each manufacturer shall conduct periodic inspections in accordance with established procedures to ensure adherence to applicable equipment maintenance schedules. The inspections, including the date and individual(s) conducting the inspections, shall be documented.(3)Adjustment. Each manufacturer shall ensure that any inherent limitations or allowable tolerances are visibly posted on or near equipment requiring periodic adjustments or are readily available to personnel performing these adjustments.(h)Manufacturing material. Where a manufacturing material could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device's quality. The removal or reduction of such。