21 CFR 820 美国FDA,质量体系(QS)法规医疗器械良好生产规范(中文),2020年5月最新版

21 CFR § 820Quality System Regulation质量体系手册Subpart A—General ProvisionsA部分——总则Scope.范围Definitions.定义Quality system.质量体系Subpart B—Quality System Requirements B部分——质量体系要求Management responsibility.管理者职责Quality audit.质量审核Personnel.职员Subpart C—Design ControlsC部分——设计控制Design controls.设计控制Subpart D—Document ControlsD部分——文件控制Document controls.文件控制Subpart E—Purchasing ControlsE部分——采购控制 Purchasing controls.采购控制Subpart F—Identification and TraceabilityF部分——标识和可追溯性Identification.标识Traceability.可追溯性Subpart G—Production and Process ControlsG部分——生产和过程控制Production and process controls.产品和过程控制,measuring, and test equipment.检查、测量，测试仪器Process validation.过程确认Subpart H—Acceptance ActivitiesH部分—接收活动Receiving, in-process, and finished device acceptance.接收设备准则，过程设备准则，最终设备准则Acceptance status.接收状态Subpart I—Nonconforming ProductI部分——不合格产品Nonconforming product.不合格产品Subpart J—Corrective and Preventive ActionJ部分——纠正预防措施Corrective and preventive action.纠正预防措施Subpart K—Labeling and Packaging ControlK部分——标签与包装控制Device labeling.产品标识Device packaging.产品包装Subpart L—Handling, Storage, Distribution, and InstallationL部分——操作、存储、分配以及安装Handling.操作Storage.存储Distribution.分配 Installation.安装Subpart M—RecordsM部分——记录General requirements.总要求Device master record.产品控制记录Device history record.产品历史记录Quality system record.质量体系记录Complaint files.客户抱怨文件Subpart N—ServicingServicing.Subpart O—Statistical TechniquesStatistical techniques.Authority: Secs. 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the Federal Food, Drug, and Cosmetic Act (21 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383).Subpart A—General Provisions................................... 错误!未定义书签。

培训教材美国FDA医疗器械体系法规QSR820中文版Part820820.1820.3820.5SubpartD-文件控制820.40 文件控制SubpartE-采购控制820.50 采购控制SubpartF-标识与可追溯性820.60 标识820.65 可追溯性SubpartG-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SubpartH-验收活动:SubpartI820.170 安装SubpartL–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SubpartM–服务820.200 服务SubpartN–统计技术820.250 统计技术（a（1和控制品法案（2,（3（b规，包括本章此部分和其它部分的情况，特别是对讨论中的设备，此法规应取代其它通用要求。

伪劣产品。

这类产品及对此不符合负责的任何个人，将依法被起诉。

（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（Part820）所进行的检查，可按section801（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section520（f）和本部分（Part820）的要求，可按本法令section501（h）条款判定在此条件下制造的产品为伪劣产品。

（e）豁免或特别许可/Exemptionsorvariances（1）任何人希望得到任何（2）在有关部门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，则器械就不可能充分有效的生产的情况下，特别许可才有效。

(2)FDAmayinitiateandgrantavariancefromanydevicequalitysystemrequirementwhentheagencydeterminesthatsuchva rianceisinthebestinterestofthepublichealth.Suchvariancewillremainineffectonlysolongasthereremainsapublichealthne edforthedeviceandthedevicewouldnotlikelybemadesufficientlyavailablewithoutthevariance.（f）本部分不适用于本章897部分定义的烟草销售商。

FDA 质量体系规范中文版 (QSR8201.1 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一部分操作 , 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 .。

美国FDA《联邦规章典集》（CFR）第21篇目录中文版发布时间：2010-5-11 13:44:12 发布方：奥咨达医疗器械咨询美国《联邦规章典集》（CFR）第21篇“食品与药品”总目概述：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”（Tit le 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 ADMINIST RATION, 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 FOODS104 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 IN MANUFACTURING, 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 PRODUCTS152 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 COMPONENTS177 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 SANITIZERS 179 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 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 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 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 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 USE332 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 FOR OVER-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 FOR OVER-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 FOR OVER-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 FOR OVER-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 FOR OVER-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 GENERALLYRECOGNIZED 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（SUB CHAPTER 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 DRUGS524 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 FEED590-599 [预留的] [Reserved]第F分章―生物制品（SUB CHAPTER 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 FOR LABORATORY 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 STANDA RDS 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: GENERAL1020 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 AND TISSUE-BASED PRODUCTS 1272-1299 [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 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 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 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]。

美国联邦法规法典第21册第I章健康与人类服务部食品与药品管理局第H小章医疗器械第820部分质量体系法规2014年4月子部分A---总则§820.1范围(a)适用性(1)质量体系法规规定了对现行良好制造法规(CGMP)的要求。

本部分的要求，决定了预期为人类使用的所有成品器械的设计、制造、包装、标记、储存、安装和服务中使用的方法、设施和控制。

本部分的要求意在确保成品器械安全、有效，并且符合联邦食品、药品和化妆品法令。

本部分确定的基本要求适用于成品医疗器械的制造商。

如果制造商仅从事受本法规的要求制约的某些操作，其它操作不受制约，则制造商只须符合适用其操作的要求。

对于I类器械，设计控制只适用于在§820.30(a)(2)中列出的器械。

本法规不适用于为成品器械提供组件或零件的制造商，但鼓励他们将本法规中的适当规定作为指导。

人类血液及血液成分的制造商不受法规本部分的约束，但受本章606部分的约束。

如同本章1271.3(d)所定义的那样，人类细胞、组织、细胞组成的和基于人体组织的产品（HCT /PS)，属于医疗器械产品（遵循上市前评审或通知，或豁免通知，基于一种据法案之器械规定所提交的申请或基于一种符合公卫生服务法案第351节的生物产品许可申请），这些产品遵循本法规且也遵循本章的第1271部分C子部分阐明的捐赠者一合格性程序以及第1271部分D子部分之适用的现行优良组织规范程序。

若发生第1271部分的适用规章与本章的其他部分相矛盾的情况，专门适用于所讨论器械的规章将取代较为一般的规章。

(2)联邦法规法典本部分的规定应适用于由本部分定义的、预期为人类使用的任何成品器械，只要这些器械在在美国任何州或领土、哥伦比亚特区或波多黎哥共同体制造、向其进口或提供向其进口。

(3)本法规多次使用了词组“适当时”。

当一项要求冠以“适当时”，除非制造商能以文件形式提出其它合理理由，它即被认为是“适当的”。

一项要求如果不予实施，即有理由认为预期产品不满足其规定的要求，或者制造商不能采取任何必要的纠正措施，则此种要求是“适当的”。

医疗器械包装要求法规医疗器械包装是指用于保护和包装各种类型的医疗器械，以确保其在运输、储存和使用过程中不受损坏或受到污染。

医疗器械包装的规定是为了确保医疗器械在包装过程中的安全性、有效性和合规性。

以下是一些国际和国内的医疗器械包装要求法规。

2.欧盟医疗器械法规（EUMDR）：欧盟于2024年实施的医疗器械法规（EUMDR）对医疗器械的包装也有相关规定。

该法规要求医疗器械必须提供有效的包装，以确保其在运输和存储过程中的安全性和有效性，并提供必要的信息，使用户能够正确和安全地使用。

3.美国食品药品监督管理局（FDA）：FDA对医疗器械包装也有相关规定，在21CFR820中进行了规范。

该规定要求医疗器械应具有适当的包装，以确保其在运输、储存和使用过程中的安全性和有效性。

4.国家药品监督管理局：我国对医疗器械包装也有相关规定，主要由国家药品监督管理局负责制定和执行。

根据《医疗器械生产质量管理规范》（2024年修订版）和《医疗器械生产许可证管理办法》（2024年修订版）等规定，医疗器械的包装应满足安全、有效、清洁、便于使用和保存等要求。

此外，各国还有一些其他的医疗器械包装要求法规，如加拿大医疗器械规范（CMDCAS）、澳大利亚治疗性商品管理办法（TGAs）等。

这些法规的制定旨在确保医疗器械在包装过程中的质量和安全性，从而保护患者和使用者的健康和安全。

综上所述，医疗器械包装要求法规是保障医疗器械包装的质量和安全性的重要依据，各国都有相应的规定和标准。

医疗器械生产企业应依据相关法规和标准，制定与医疗器械包装相关的质量管理体系，并严格执行，以确保医疗器械在包装过程中的合规性和安全性。

同时，监管机构也应加强监督和执法，确保医疗器械包装符合法规要求。

（完整版）美国FDA《联邦规章典集》（CFR）第21篇目录中文版美国FDA《联邦规章典集》（CFR）第21篇目录中文版发布时间：2010-5-11 13:44:12 发布方：奥咨达医疗器械咨询美国《联邦规章典集》（CFR）第21篇“食品与药品”总目概述：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”（Tit le 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 EnforcementAdministration，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 Drug s）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 ADMINIST RATION, 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 RESTRICTIONSFOR 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 FOODS104 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 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 IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD 113 装在密封容器中的热加工低酸食品THERMALLYPROCESSED 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 PRODUCTS152 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: 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 SANITIZERS 179 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 ADDITIONALSTUDY181 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 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 INMANUFACTURING, 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 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 INGESTIONTHAT 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 USE332 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 FOR OVER-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 FOR OVER-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 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 USE 348 用于非处方的人类使用的外部的止痛药品EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-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 FOR OVER-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 FOR OVER-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（SUB CHAPTER 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 DRUGS524 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 ANIMALS 579 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 FEED590-599 [预留的] [Reserved]第F分章―生物制品（SUB CHAPTER 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ADDITIONALSTANDARDS 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 FOR LABORATORY 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―COSMETIC S）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 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 STANDA RDS 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: GENERAL1020 电离辐射发生产品的性能标准PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS 1030 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 FORLIGHT-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 AND TISSUE-BASED PRODUCTS 1272-1299 [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 OFREGISTRANTS1305 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]。

针对21 CFR Part 820法规的讲解一、FDA的定义FDA（U.S. Food and Drug Administration）的简称，即美国食品药品监督管理局。

它是健康与人类服务部下属的一个机构，由各个中心、办公室、地区办公室以及海外办公室组成。

二、联邦法规条例，第21册相关法规说明21 CFR Part 11 电子签名、电子记录（FDA检查时尽量避免给电子档文件）。

21 CFR Part 71.73.74.80 颜色添加剂。

21 CFR Part 58 良好的实验室规范。

21 CFR Part 50 受试者的保护。

21 CFR Part 801 医疗器械标识。

21 CFR Part 807 注册、列示、510（K）510（K）主要是针对产品的许可，包括了产品的生产商、配件生产商、一级销售商，任何一个独立地址的生产厂都必须向FDA注册。

列示：是指针对销售美国的所有产品都要列示。

21 CFR Part 814 上市前许可。

21 CFR Part 803 医疗器械报告。

21 CFR Part 806 纠正与移除。

21 CFR Part 820 质量体系法规。

21 CFR Part 821 医疗器械追踪。

三、第820部分质量体系法规条款框架（共15部分，31章节）（a）适用性（b）法规说明820.1范围（c）权威性（d）外国制造商A部分总则（e）豁免或改变820.3定义820.5质量体系（a）质量方针（1）职责和权限（b）组织（2）资源820.30管理职责（c）管理评审（3）管理者代表B部分质量体系要求820.22质量审核（d）质量策划（e）质量体系程序820.25人员（a）总则（b）培训（a）总则（b）设计和开发策划（c）设计输入（d）设计输出（e）设计评审C部分设计控制----- 820.30设计控制（f）设计验证（g）设计确认（h）设计转换（i）设计更改（j）设计历史文档（a）文件批准和分发D部分文件控制----- 820.40文件控制（b）文件更改（a）采购、承包方和顾问的评价E部分采购控制----- 820.50采购控制（b）采购资料820.60标识F部分标识和可追溯性820.65 可追溯性（a）总则（b）生产和过程更改（c）环境控制（d）人员820.70 生产和过程控制（e）污染控制（f）建筑物1）维护计划（g）设备（2）检查（h）制造物料（3）调整（i）自动化过程G部分生产和过程控制（a）检验、测量和试验装置控制820.72校验、测量和试验装置（1）校准标准（b）校准（2）校准记录820.75过程确认（a）总则（b）进货验收活动820.80 进货、过程中和成品（c）过程中验收活动器械的验收（d）最终验收活动H部分验收活动（e）验收记录820.86 验收状态（a）不合格产品控制I部分不合格产品------ 820.90 不合格产品（b）不合格评审和处置J部分纠正和预防措施----820.100纠正和预防措施（a）标签完整性（b）标记检验820.120 器械标识（c）标识存储K部分标识和包装控制（d）标签作业820.130 器械包装（e）控制号820.140 搬运（a）对存储区规定文件820.150 存储L部分搬运、存储、分销和包装820.160 分销（b）物料收发方法规定文件820.170 安装（a）机密性820.180 通用要求（b）记录保存期限（1）管理评审（c）例外（2）质量审核（a）器械规范（3）供方审核（b）生产过程规范820.181 器械主记录（c）质量保证程序和规范（d）包装和标识规范（e）安装、维护和服务程序及方法（a）制造日期M部分记录（b）制造数量820.184器械的历史记录（c）放行分销的数量（d）验收记录（e）器械上的主要标签和标识记录（f）器械唯一标识UDI和产品代码UPC820.186 质量体系记录1、抱怨接收流程820.198 抱怨文档2、抱怨评估流程3、抱怨审核流程N部分服务----- 820.200 服务O部分统计技术----- 820.250 统计技术。

企业对21 CFR Part 820 QSR的理解-1美国国会是法律的制定机构. 其制定的<联邦食品,药品和化妆品法案(Federal Food, Drug, and Cosmetic Act)>是美国关于医疗器械管理的最高法律性文件.美国食品药品监督管理局(FDA)是负责医疗器械管理的政府机构.其根据各相关法律授权而制定的各类法规性的文件编号为21CFRxxxx(xxxx为阿拉伯数字).其中21CFR820是FDA根据<联邦食品,药品和化妆品法案>第501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803条款的授权而制定的规范医疗器械企业质量体系要求的法规,即Quality System Regulation,简称QSR或QSR820.谁要遵守QSR820?21QSR820.1规定,所有在美国和波多黎各境内的,或者有产品出口到美国和波多黎各境内的医疗器械企业必须按QSR820的要求建立质量体系.各企业可以根据实际情况,满足QSR中与自己活动相关的条款.QSR820不适用于医疗器械零件生产商,但FDA鼓励这类企业以QSR820中适用的条款为指导.QSR820不适用于人血和血制品生产商.这类企业应遵循21CFR606的规定.谁来检查企业是否符合QSR820?FDA下属的CDRH(器械与放射健康中心)是专职负责医疗器械企业管理的政府机构,其根据FDA的授权安排检查员到个企业进行工厂检查.对美国境内企业一般每两年检查一次,境外企业不定期检查.所有检查费用由FDA承担.在欧洲和美国本土,FDA也授权TUV等第三方机构进行工厂检查,扥企业要支付相应费用.无论谁来检查,都只是一个符合性检查,不颁发任何证书,不属于认证活动.如何检查企业是否符合QSR820?QSIT(质量体系检查技术)是FDA检查员的必修课程,也是FDA Quality Systems Inspection Reengineering Team专门编制的检查员手册.该文件详细介绍了检查方法,关注点,无论对FDA检查员还是企业内审员/供应商审核员都具有参考价值. QSR820概况现行版本的QSR820颁布于1996年10月7日,正式生效于1997年6月1日,亦被称为美国医疗器械行业的现行良好的规范(Current Good Manufacture Practice,简称cGMP).全文一共15个章节:A总则B质量体系要求C设计控制D文件控制E采购控制F识别与可追溯性G生产于过程控制H验收活动I不合格产品J纠正与预防措施K标签与包装控制L搬运,存储,发运与安装M记录N服务O统计技术总体而言，这是一套在结构上不同于IS013485：2003，要求上与IS013485：2003基本相同，规定上更加明确的质量管理体系法规：(括号内为IS013485：2003对应条款)B: 质量体系要求(4.1, 5, 6.2, 8.2.2)C: 设计控制(7.3)D: 文件控制(4.2)E: 采购控制(7.4)F: 识别与可追溯性(7.5.3)G: 生产与过程控制(7.5, 6.3, 6.4, 7.6)H: 验收活动(8.2.4)I: 不合格产品(8.3)J: 纠正与预防措施(8.5.2, 8.5.3)K:标签与包装控制L:搬运、存储、发运与安装(7.5.5, 7.5.1)M:记录(4.2, 8.5.1)N:服务(7.5.1)O:统计技术(8.1)FDA认为,企业的质量体系涉及到七个主要流程:各流程对应的章节QSR820-管理流程(Management)企业应建立质量方针.应确定质量工作人员的职责、权限和相互关系．应书面任命一名管理者代表.应定期多次进行管理评审.企业应进行内审.并保留相关记录(包括内审、发现的不合格、不合格的整改及整改后的重新审核.内审报告应发给被审核要素的责任部门。

美国FDA《联邦规章典集》（CFR）第21篇目录中文版发布时间：2010-5-11 13:44:12 发布方：奥咨达医疗器械咨询美国《联邦规章典集》（CFR）第21篇“食品与药品”总目概述：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”（Tit le 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 ADMINIST RATION, 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 FOODS104 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 IN MANUFACTURING, 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 PRODUCTS152 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 COMPONENTS177 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 SANITIZERS 179 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 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 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 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 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 USE332 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 FOR OVER-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 FOR OVER-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 FOR OVER-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 FOR OVER-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 FOR OVER-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 GENERALLYRECOGNIZED 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（SUB CHAPTER 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 DRUGS524 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 FEED590-599 [预留的] [Reserved]第F分章―生物制品（SUB CHAPTER 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 FOR LABORATORY 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 STANDA RDS 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: GENERAL1020 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 AND TISSUE-BASED PRODUCTS 1272-1299 [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 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 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 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]。

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。

金姆·特劳特曼（Kim Trautman）制作人员: 芭芭拉·理查德斯（Barbara Richards）各位好。

我叫金姆·特劳特曼，是食品药品管理局（FDA）下属的器械与放射性健康中心的医用器械质量系统专家。

今天我们来探讨质量系统法规以及《美国联邦法规法典》第21册第820部分（下称21 CFR 820）中提出的有关规定。

这将是一个非常简单的介绍，因为有关规定非常多，我们可以就此提供一些长达一周的课程。

这里我们将试着就法规中的一些基本规定为大家提供一个总览。

现在，我们来介绍一下背景资料以及形成这些规定的历史。

我们会谈到一些重要的定义，然后我们再谈谈一些分支系统。

在书面文件中，事物总是线性的，你们总要先有一个规定，然后再有另外一个规定。

但是，在一个质量管理系统中却有更多的所谓分支系统或程序在相互提供着支持。

今天我们将要谈到的四个主要分支系统包括管理控制、设计与研发控制、生产与过程控制、以及纠正与预防措施。

我们还将在最后列出其他一些你们可能更希望见到的或听完这个单元后会去寻找的信息资源。

实际上，在1997年6月1日，我们替换了1978年的GMP法规。

所以说，原有的GMP法规，即良好制造法规，是早在1978年医用器械的法规生效时颁布的。

这个法规一直到我们颁布了1997质量系统法规以后才失效。

1997法规的导言非常重要。

这个导言虽然有点长，但却相当值得一1金姆·特劳特曼（Kim Trautman）制作人员: 芭芭拉·理查德斯（Barbara Richards）读，因为它告诉你们本机构在颁布或制订21 CFR 820中的那些规定时的意图。

此外，导言中所述本机构的意图还可以在法庭上使用，以表明本机构的原意为何。

而且，导言还是值得你们掌握的很好的教育信息。

质量系统法规中的要求都是最基本的，然而并非是刻板的。

医用器械业生产的器械种类繁多，从简单的注射器到体外诊断用的IVD，到非常复杂的临床分析机，还有医用电子器械，甚至还有复合产品和纳米技术。

FDA QSR820，也被称为QSR (Quality System Regulation)，是21 CFR 820的一种简易叫法。

这个法规重点关注当前的良好制造工艺（CGMP）和控制，这些控制用于所有拟供人使用的成品设备的设计、包装、标签、存储、安装和维修。

QSR820质量体系规范中描述了现行的生产管理规范的要求。

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。

QSR820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QSR规定的一部分操作，而不进行其他操作，这些制造商应根据实际情况满足QSR中与自己活动相关的条款。

此外，QSR820不适用于医疗器械零件生产商，但FDA鼓励这类企业以QSR820中适用的条款为指导。

同时，QSR820也不适用于人血和血制品生产商，这类企业应遵循21CFR606的规定。

以上内容仅供参考，建议查阅FDA官网获取准确信息。

培训教材美国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。

FDA 21 CFR QSR820 中英文对照版本1 / 4621 CFR § 820Quality System Regulation质量体系手册Subpart A —General ProvisionsA 部分——总则820.1 Scope.820.1范围820.3 Definitions.定义820.5 Quality system.质量体系Subpart B —Quality SystemRequirementsB 部分——质量体系要求820.20 Management responsibility.管理者职责820.22 Quality audit. 质量审核 820.25 Personnel. 职员 Subpart C —Design Controls C 部分——设计控制 820.30 Design controls. 设计控制 Subpart D —Document Controls D 部分——文件控制 820.40 Document controls. 文件控制 Subpart E —Purchasing Controls E 部分——采购控制 820.50 Purchasing controls.采购控制Subpart F—Identification and TraceabilityF部分——标识和可追溯性820.60 Identification.标识820.65 Traceability.可追溯性Subpart G—Production and Process ControlsG部分——生产和过程控制820.70 Production and process controls.产品和过程控制820.72Inspection,measuring, and test equipment.检查、测量，测试仪器820.75 Process validation.过程确认Subpart H—Acceptance ActivitiesH部分—接收活动820.80 Receiving, in-process, and finished device acceptance.接收设备准则，过程设备准则，最终设备准则820.86 Acceptance status.接收状态Subpart I—Nonconforming Product I部分——不合格产品820.90 Nonconforming product.不合格产品Subpart J—Corrective and Preventive ActionJ部分——纠正预防措施820.100 Corrective and preventive action.纠正预防措施Subpart K—Labeling and Packaging ControlK部分——标签与包装控制820.120 Device labeling.产品标识820.130 Device packaging.产品包装Subpart L—Handling, Storage, Distribution, and InstallationL部分——操作、存储、分配以及安装820.140 Handling.操作820.150 Storage.存储820.160 Distribution.分配820.170 Installation.安装2 / 46Subpart M—RecordsM部分——记录820.180 General requirements.总要求820.181 Device master record.产品控制记录820.184 Device history record.产品历史记录820.186 Quality system record.质量体系记录820.198 Complaint files.客户抱怨文件Subpart N—Servicing820.200 Servicing.Subpart O—Statistical Techniques820.250 Statistical techniques.Authority: Secs. 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383).Subpart A—General Provisions3§ 820.1 Scope.3Subpart A—General Provisions§ 820.1 Scope.820.1范围(a) Applicability.适用性(1) Current good manufacturing practice (CGMP) requirementsare 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 and3 / 46effective 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, thatcomponents 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.在本质量体系法规（QSR）中阐述了CGMP的要求。

美国FDA 医疗器械体系法规QSR820中文版之巴公井开创作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- 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、过程和成品器械检验 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当前良好制造法规Current good manufacturing practice（CGMP）的要求。