How to Prepare a Special 510(k)
https://www.doczj.com/doc/dc12356417.html,/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm134573.htm Overview
There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm [PDF: The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance]" to help streamline the 510(k) review process.
Product modifications that could significantly affect safety and effectiveness are subject to 510(k) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls.
The "Special 510(k): Device Modification" utilizes the design control requirement of the Quality System Regulation (21 CFR 820) and may be submitted for a modification to a device that has been cleared under the 510(k) process. The Special 510(k) allows the manufacturer to declare conformance to design controls without providing the data. While the basic content requirements of the 510(k) (21 CFR 807.87) remain the same, this type of submission should also reference the cleared 510(k) number and contain a "Declaration of Conformity" with design control requirements. Manufacturers of Class I devices requiring 510(k) may elect to comply with the design control provision of the QS regulation and submit Special 510(k)s.
Manufacturers of preamendments devices may also submit Special 510(k)s. When the legally marketed (unmodified) device is a preamendments device, the submitter should clearly state that the device is a preamendments device, is legally marketed, and has not been the subject of Premarket Notification 510(k) clearance. (Refer to "Documentation Required for Preamendments Status" for the procedures for demonstrating preamendments status. Submitters should maintain this information in their files.)
A. The submitter is able to provide copies of documents that verify that the device was placed into
interstate commerce (for other than research uses or as part of a plant-to-plant transfer) and was
actually labeled and promoted for a specific intended use.
Provide dated copies of any available firm's advertisements, catalog pages, promotional material, journal article, manufacturing documents, and shipping documents (e.g., invoices, bills of lading, receipts, etc.). FDA may also consider other pieces of information to address this item. Nevertheless, the information provided (individually or collectively) must prove that there was interstate commerce of the device and that the device was labeled and promoted for a specific intended use prior to May 28, 1976. Copies of any supporting information (e.g., journal article) must be provided, not just referenced.
In addition, any supporting information must reflect the device was not used as part of any research study or for investigational use.
B. The submitter is not able to provide any of the information described in item A above.
1. Provide an affidavit from a current or former employee of the firm that distributed the device who
is, or was, in a position to be aware of the labeling and promotional information used for the device and to attest that the device was distributed prior to May 28, 1976. This affidavit must include the following:
z a statement explaining why any invoices or shipping records of pre-May 28, 1976 distribution are not available;
z detailed information relating to his/her position and how that placed he/she in a position to be aware of the preamendment labeling and promotion of the device;
z a statement that the device was not used as part of any research study or for investigational use prior to May 28, 1976;
z a statement, with any available supporting documentation, of the specific intended uses for which the device was labeled and promoted prior to May 28, 1976. Actual copies of any
supporting information (e.g., journal article) must be provided, not just referenced. Any
supporting information must not reflect the use of the device as part of any research study or
for investigational use prior to May 28, 1976; and
z a statement of his/her financial interest in the device or firm.
2. Provide an affidavit from a credible person who used the device prior to May 28, 1976. The
affidavit must include the following:
z a statement that the user has personal knowledge that the device entered interstate commerce prior to May 28, 1976;
z the name of the source and the state from which the device was shipped;
z a statement that the device was not received as part of any research study or for
investigational use prior to May 28, 1976;
z statement, with any available supporting documentation, of the specific intended uses for which the device was labeled and promoted prior to May 28, 1976. Actual copies of any
supporting information (e.g., journal article) must be provided, not just referenced; and z a statement of his/her financial interest in the device or firm.
Note: If it is not possible to obtain the affidavit for item B(1) above, then provide an affidavit documenting your efforts to obtain one, and provide affidavits from two credible users.
C. The submitter is able to provide only a portion of the information necessary to address item A
above. In this case, we may accept partial documentation from each of items A and B(1 and 2) above.
However, the submitter should attempt to address each item as complete as possible. Nevertheless, the
Background
Effective June 1, 1997, manufacturers of Class II, Class III, and certain Class I devices are required to follow design control procedures when originally developing devices and for subsequent modifications. In accordance with the Quality System Regulation, manufacturers must have a systematic set of requirements and activities for the management of design and development, including documentation of design inputs, risk analysis, design output, test procedures, verification and validation procedures, and documentation of formal design reviews. In this process, the manufacturer must ensure that design input requirements are appropriate so the device will meet its intended use and the needs of the user population. The manufacturer must also establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Thus, manufacturers may need to refine their device design requirements as verification and validation results are obtained. The design specifications that result from this process are the design outputs, which form the basis for the device master record (DMR). [See 21 CFR 820.3(i)] The DMR is subject to inspection by FDA personnel.
Since design control requirements are now in effect and require the manufacturer to conduct verification and validation studies of a type that traditionally may have been included in 510(k) submissions in the past, FDA believes that it may be appropriate to forgo a detailed review of the underlying data normally required in the 510(k) program. For this reason, FDA is allowing an alternative to the traditional method of demonstrating substantial equivalence for certain device modifications. For these well-defined modifications, FDA believes that the rigorous design control procedure requirements produce highly reliable results that can form, in addition to the other 510(k) content requirements, a basis for the substantial equivalence determination. Under the Quality Systems Regulation, data that is generated as a result of the design control procedures must be maintained by the manufacturer and be available for FDA inspection.
In order to provide an incentive for manufacturers to choose this option for obtaining FDA clearance for device modifications, the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) intend to process Special 510(k)s within 30 days of receipt by the Document Mail Center (DMC). The Special 510(k) option allows FDA to review modifications that do not affect the device's
intended use or alter the device's fundamental scientific technology within this shorter time frame. FDA does not believe that modifications that affect the intended use or alter the fundamental scientific technology of the device are appropriate for review under this type of submission, but rather should continue to be subject to the traditional 510(k) procedures [i.e., "Traditional 510(k)") or may be subject to an Abbreviated 510(k)].
Criteria for a Special 510(k)
Under the New 510(k) Paradigm, a manufacturer should refer to 21 CFR 807.81(a)(3) and the FDA guidance document entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device, [PDF: Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)]" to decide if a device modification may be implemented without submission of a new 510(k). If a new 510(k) is needed for the modification and if the modification does not affect the intended use of the device or alter the fundamental scientific technology of the device, then summary information that results from the design control process can serve as the basis for clearing the application along with the required elements of a 510(k) found in 21 CFR 807.87.
To optimize the chance that a Special 510(k) will be accepted and promptly cleared, 510(k) submitters should evaluate each modification against the considerations described below to insure that the particular change does not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
Intended Use
Modifications to the indications for use of the device or any labeling change that affects the intended use of the device will not be accepted as a Special 510(k). Therefore, FDA recommends that
submitters of Special 510(k)s highlight, or otherwise prominently identify, all changes in the proposed
labeling that may result from modifications to their legally marketed device. In addition, it should be
clearly stated in the Special 510(k) that the intended use of the modified device, as described in its
labeling, has not changed as a result of the modification(s). Please note that a labeling change from
prescription use to over the counter use, or vice versa, is considered a change in intended use and,
therefore, is not eligible for the Special 510(k) method.
Fundamental Scientific Technology
Special 510(k)s also will not be accepted for modifications that have the potential to alter the fundamental scientific technology of the device. These types of changes generally include modifications to the device's operating principle(s) or mechanism of action, such as automation of a manual device or
incorporation of a sensing or feedback circuit. Specific examples that illustrate these types of changes
that alter the fundamental scientific technology and thus should not be submitted as Special 510(k)s
include:
1. A change in a surgical instrument that uses a sharpened metal blade to one that cuts with at a
laser;
2. A change in an in vitro diagnostic (IVD) device that uses immunoassay technology to one that
uses nucleic acid hybridization or amplification technology;
3.Incorporation of a sensing mechanism in a device to allow the device to function "on demand"
rather than continuously.
In addition, FDA is concerned with changes in materials in certain devices. While FDA acknowledges that many such changes can be processed as Special 510(k)s, there are certain types of
changes in materials that may raise safety or effectiveness issues that continue to warrant a more
intensive evaluation. This includes a change in material(s) in an implant, or other device that contacts
body tissues or fluids, to a material type that has not been used in other legally marketed devices within
antiseptic that had not been previously used in a legally marketed predicate, such a change would not be appropriate for review as a Special 510(k). Both of the above types of modifications involve major changes in the principle component of the device and thus would be considered a change to the fundamental scientific technology of the device and should be submitted for review as either Abbreviated or Traditional 510(k)s.
A change, however, in formulation in a material or a change to a type of material that has been used in other legally marketed devices within the same classification regulation for the same intended use could be reviewed as a Special 510(k). This should be true for both non-contacting devices as well as implants and devices that contact body tissues or fluids. Thus, a manufacturer of a hip implant could change from one alloy to one that has been used in another legally marketed predicate through the submission of a Special 510(k). Similarly, a contact lens manufacturer could submit a Special 510(k) for a change in their polymer to another material that has been used in a legally marketed predicate. Finally, changes in an inactive or secondary ingredient/agent should be appropriate for review as Special 510(k)s as this should not be considered a major change to the fundamental scientific technology of the device. For example, a manufacturer of a urologic catheter could submit a Special 510(k) to add an antimicrobial coating to the device if the coating has been used on another legally marketed predicate of the same material.
Device modifications that should be appropriate for review as Special 510(k)s also include those changes identified below:
z Energy type
z Environmental specifications
z Performance specifications
z Ergonomics of the patient-user interface
z Dimensional specifications
z Software or firmware
z Packaging or expiration dating
z Sterilization
It should be noted that in cases where FDA has issued guidance, established special controls, or recognized standards that address issues such as device testing or performance, manufacturers should consider this in their implementation of design control requirements. For example, if a manufacturer is modifying a contact lens, then the manufacturer's design control inputs should include the special controls that FDA has established for this device. Further, if a manufacturer modifies an in vitro diagnostic, the manufacturer's design inputs should include any recognized clinical standards such as those developed by NCCLS (formerly known as National Committee of Clinical Laboratory Standards) or a reasonable alternative. Thus, submitters of Special 510(k)s need to be aware of any relevant guidance documents, special controls, or recognized standards that apply to their device and that should be addressed by their design control processes.
Clinical Considerations
including 21 CFR Parts 812, 50 and 56. Collection of clinical data to support a Special 510(k) may
require submission of an Investigational Device Exemptions (IDE) application to FDA. The fact that a
significant risk device investigation was conducted to support any of the activities listed above, however, does not necessarily preclude the submission of a Special 510(k).
Manufacturers who intend to conduct clinical investigations of a modified device as part of design validation are encouraged to contact the appropriate ODE review division before
preparing a Special 510(k). When a clinical investigation is necessary to answer safety and
effectiveness questions relating to a particular modification, FDA believes that the modification is likely to have gone beyond that which is suitable for review as a Special 510(k). In contrast, where design
validation involves clinical evaluation intended to ensure that the modified device meets user
requirements as opposed to patient safety and effectiveness or to demonstrate continued conformance
with a special control or recognized standard, FDA believes that the Special 510(k) may be the
appropriate submission.
If FDA determines that a Special is not eligible for review as submitted, the FDA reviewer will notify the firm of this decision and offer the option of having the document converted to a Traditional 510(k) or withdrawing it for future submission. If the 510(k) is converted, the original receipt date remains as the start of the review period. Manufacturers should be aware that, in most cases, additional information will be necessary for converted documents.
Conformance Assessment
In the Special 510(k) process, a manufacturer who is intending to modify his/her own legally marketed device will conduct the risk analysis and the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements. Once the manufacturer has ensured the satisfactory completion of this process, a "Special 510(k): Device Modification" may be submitted.
Under the Quality System Regulation, manufacturers are responsible for performing internal audits to assess their conformance with design controls. A manufacturer could, however, use a third party to provide a supporting assessment of the conformance. (This use of a third party should not be confused with FDA's Third Party Review Program where recognized third parties review entire 510(k) submissions.) In this case, the third party will perform a conformance assessment for the device manufacturer and provide the manufacturer with a statement to this effect. The marketing application should then include a declaration of conformity signed by the manufacturer, while the statement from the third party should be maintained in the Device Master Record (DMR). As always, responsibility for conformance with design control requirements rests with the manufacturer. Under the Quality Systems Regulation, data that is generated as a result of the design control procedures must be maintained by the manufacturer and be available for FDA inspection.
Content/Format of a Special 510(k)
A Special 510(k) should be well organized and formatted in sections, with page numbering, and include the required elements:
z Medical Device User Fee Cover Sheet (Form FDA 3601) [PDF: Sample：Medical Device User Fee Cover Sheet]. See 510(k) Review Fees
[https://www.doczj.com/doc/dc12356417.html,/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/Premar
ketSubmissions/PremarketNotification510k/ucm134566.htm] for additional information on review fees.
z CDRH Premarket Review Submission Cover Sheet (FDA Form 3514) [PDF: CDRH Premarket Review
Submission Cover Sheet]
z Certification of Compliance with https://www.doczj.com/doc/dc12356417.html, Data Bank, FDA-3674* [PDF: Certification of Compliance with https://www.doczj.com/doc/dc12356417.html, Data Bank]
z*Beginning December 26, 2007, all 510(k) submissions must include a completed copy of form FDA-3674. See Form FDA-3674, https://www.doczj.com/doc/dc12356417.html, Data Bank for additional information.
Form FDA-3674, https://www.doczj.com/doc/dc12356417.html, Data Bank
Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) included a provision that all 510(k) submissions are required to be accompanied with certification that all applicable clinical trial information has been submitted to the https://www.doczj.com/doc/dc12356417.html, data bank.
The agency has issued for comment a draft guidance, titled: "Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance with Section 402(j) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007". According to the draft guidance, 510(k) submissions that do not contain clinical data do not need the not need the certification form. Anyone wishing to comment on the draft guidance is requested to submit electronic or written comments within 60 days.
If your 510(k) includes data from a clinical trial, you must determine if your study is applicable for entry into the clinical trial registry data bank at https://www.doczj.com/doc/dc12356417.html,. Based on this determination, check box 9.B. or 9.C., and complete the applicable sections of the form. An applicable device clinical trial is a prospective clinical study of health outcomes comparing an intervention with a device against a control in human subjects (other than a small clinical trial to determine the feasibility of a device, or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes). See Title VIII - Clinical Trial Databases [PDF: Title VIII - Clinical Trial Databases]. Currently, FDA is reviewing the legislation and developing guidance on which clinical trials meet the definition of "applicable" trials and are required to report to https://www.doczj.com/doc/dc12356417.html,. Until FDA issues this guidance, 510(k) submitters are responsible for determining whether their studies meet the definition of an applicable trial and, therefore, are subject to reporting requirements.
Information on how to register your clinical trial(s) in the https://www.doczj.com/doc/dc12356417.html, data bank is available on the National Library of Medicine (NLM) Protocol Registration System (PRS) website
[https://www.doczj.com/doc/dc12356417.html,/].
z Cover Letter, clearly identifying the application as a "Special 510(k)." Include 510(k) holder name, address, and facility registration number, if available.
z Table of Contents (recommended)
z510(k) Screening Checklist (recommended) [PDF: Screening Checklist for Traditional／Abbreviated Premarket Notification [510(k)] Submissions]
z Statement of Indications for Use
Statement of Indications for Use
Prepare a Statement of Indications for Use as a separate page. We recommend that you use the Indications for Use format. Use the ODE recommended format [PDF: Indications for Use(ODE)] for submissions to ODE and the OIVD recommended format [PDF: Indications for Use(OIVD)] for submissions to OIVD. The statement should include specific indications, clinical settings, define the target population, anatomical sites, etc. This statement must be consistent with your labeling, advertising and instructions for use. Once the review is complete, FDA will include the Indications for Use Statement with the Substantial Equivalence (SE) letter to the applicant and make it
available to the public on the Internet.
z510(k) Summary [21 CFR 807.92] or 510(k) Statement [21 CFR 807.93]
510(k) Summary
If you choose to meet the conditions for a 510(k) summary (21 CFR 807.92), it must be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence. As required by section 807.92(a), FDA will accept summaries or amended summaries until FDA issues a determination regarding substantial equivalence.
The 510(k) summary must contain the information described below. Please make a copy of the following to use as a checklist and check off each item to make sure your summary is adequate and complete.
[ ] The summary should be in a separate section of the submission. It should begin on a new page and end on a page not shared with any other part of the 510(k) submission. It is clearly identified as "510(k) Summary" as required by section 807.92(c).
[ ] The summary contains on the first page, preferably on your letterhead paper, the 510(k) owner's name, address, phone and fax numbers, name of contact person, and date the summary was prepared [807.92(a)(1)].
[ ] The summary includes the name of the device, including the trade or proprietary name, if applicable, the common or usual name, and the classification name, if known [807.92(a)(2)].
Example:
z Trade name - DRAG@N LATEX EXAMINATION GLOVES
z Common name - exam gloves
z Classification name - patient examination glove (21 CFR 880.6250, Product Code FMC)
[ ] The summary identifies the legally marketed device to which your firm is claiming equivalence [807.92(a)(3)].
[ ] The summary includes a description of the device such as might be found in the labeling or promotional material for the device, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such as device design, material used, and physical properties; [807.92(a)(4)].
[ ] The summary provides the intended use of the device including a general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including a description, where appropriate, of the patient population for which the device is intended. If the indication statements are different from those of the predicate device, the 510(k) summary shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used as labeled [807.92(a)(5)].
[ ] The 510(k) summary contains a summary of the technological characteristics of your device compared to the predicate device. If the device has the same technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate device, a summary of the technological characteristics of the new device in comparison to those of the predicate device should be included. If your device has different technological characteristics from the predicate device, provide a summary of how the technological characteristics of your device compare to the predicate device. [807.92(a)(6)]
[ ] If the determination of substantial equivalence is also based on an assessment of non-clinical performance data, the summary includes a brief discussion of the nonclinical tests submitted, referenced, or relied on in
the premarket notification submission for a determination of substantial equivalence and how their results support a determination of substantial equivalence [807.92(b)(1)].
[ ] If the determination of substantial equivalence is also based on an assessment of clinical performance data, the summary includes a brief discussion of clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence and how their results support a determination of substantial equivalence. This discussion shall include, where applicable, a description of the subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a determination of substantial equivalence [807.92(b)(2)]. Please note: Clinical data is not needed for most devices cleared by the 510(k) process.
[ ] The summary includes the conclusions drawn from the nonclinical and clinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device . 807.92(b)(3)
[ ] The summary includes any other information reasonably deemed necessary by FDA. Such requests will be made directly to the applicant by FDA or the requirements will be published in guidance documents. Additional information requested by FDA during review of the 510(k) may include additional safety and effectiveness information which may necessitate an update of your summary if requested by FDA. 807.92(d)
[ ] Please make sure you have included all of the information listed above and verify that the following criteria have been met.
z The summary includes only information that is also covered in the body of the 510(k).
z The summary does not contain any puffery or unsubstantiated labeling claims.
z The summary does not contain any raw data, i.e., contains only summary data.
z The summary does not contain any trade secret or confidential commercial information.
z The summary does not contain any patient identification information.
FDA will place the summary on the Internet 30 days following the substantial equivalent decision.
510(k) Statement
If you choose to submit a 510(k) Statement, the regulation requires the specific statement as provided in 21 CFR 807.93. The statement should be clearly identified as "510(k) Statement" and must be signed by the certifier, not a consultant to the 510(k) submitter.
Premarket Notification 510(k) Statement
(As Required By 21 CFR 807.93)
I certify that, in my capacity as (the position held in company by person required to submit the premarket notification, preferably the official correspondent) of (company name), I will make available all information included in this premarket notification on safety and effectiveness within 30 days of request by any person if the device described in the premarket notification submission is determined to be substantially equivalent. The information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient identifiers, and trade secret and confidential commercial information, as defined in 21 CFR 20.61.
______________________________
(Signature of Certifier)
______________________________
(Typed Name)
______________________________
(Date)
______________________________
*(Premarket Notification [510(k)] Number)
*For a new submission, leave the 510(k) number blank.
[Code of Federal Regulations]
[Title 21, V olume 8]
[Revised as of April 1, 2011]
[CITE: 21CFR807.93]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 807 -- ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
Subpart E--Premarket Notification Procedures
Sec. 807.93 Content and format of a 510(k) statement.
(a)
(1) A 510(k) statement submitted as part of a premarket notification shall state as follows:
I certify that, in my capacity as (the position held in company by person required to submit the
premarket notification, preferably the official correspondent in the firm), of (company name), I will make available all information included in this premarket notification on safety and effectiveness
within 30 days of request by any person if the device described in the premarket notification
submission is determined to be substantially equivalent. The information I agree to make available
will be a duplicate of the premarket notification submission, including any adverse safety and
effectiveness information, but excluding all patient identifiers, and trade secret and confidential
commercial information, as defined in 21 CFR 20.61.
(2) The statement in paragraph (a)(1) of this section should be signed by the certifier, made on a separate
page of the premarket notification submission, and clearly identified as "510(k) statement."
(b) All requests for information included in paragraph (a) of this section shall be made in writing to the certifier, whose name will be published by FDA on the list of premarket notification submissions for which substantial equivalence determinations have been made.
(c) The information provided to requestors will be a duplicate of the premarket notification submission, including any adverse information, but excluding all patient identifiers, and trade secret and confidential commercial information as defined in 20.61 of this chapter.
[59 FR 64295, Dec. 14, 1994]
For a new submission, leave the space for the 510(k) number blank. You will receive your 510(k) number in your 510(k) acknowledgment letter. The 510(k) document control number begins with the letter K followed by 6 digits.
If you elect to prepare a signed 510(k) Statement, anyone may request a copy of the 510(k) [with patient identifiers, trade secret and confidential information deleted] from the applicant of record. These written requests must be filled within 30 days. 510(k) owner's may not charge requesters for compiling and disseminating this data. Noncompliance with the 510(k) statement will be deemed a prohibited act under section 301(p) of the FD&C Act and FDA may choose to use its enforcement powers to obtain compliance.
z Standards Data Report for 510(K)s - FDA 3654 [PDF: Standards Data Report for 510(k)s] Submit this form if your 510(k) references a national or international standard.
z Truthful and Accuracy Statement
Truthful and Accurate Statement
All 510(k) submitters must include a statement certifying that all information submitted in the 510(k) is truthful and accurate and that no material fact has been omitted. The statement may be included in the 510(k) Cover Letter or may be on a separate page identified in the table of contents. If the CDRH Premarket Review Submission Cover Sheet is used, the statement should attached as a separate page. Truthful and Accurate Statement
Premarket Notification Truthful And Accurate Statement
[As Required by 21 CFR 807.87(k)]
I certify that, in my capacity as (the position held in company) of
(company name), I believe to the best of my knowledge, that all data
and information submitted in the premarket notification are truthful and
accurate and that no material fact has been omitted.
_____________________________
(Signature)
______________________________
(Typed Name)
______________________________
(Date)
_______________________________
*(Premarket Notification [510(k)] Number)
*For a new submission, leave the 510(k) number blank.
Must be signed by a responsible person of the firm required to submit the premarket notification [e.g., not nsu
a co ltant for the 510(k) submitter].
z Class III Certification and Summary (if applicable)
Premarket Notification Class III Certification and Summary
(As Required by 21 CFR 807.94)
(To be submitted when claiming equivalence to a Class III device)
I certify that, in my capacity as (the position held in company) of
(company name) that I have conducted a reasonable search of all information known or otherwise available about the types and causes of safety and/or effectiveness problems that have been reported for the (device name). I further certify that I am aware of the types of problems to which the (device name) is susceptible and that, to the best of my knowledge, the following summary of the types and causes of safety and/or effectiveness problems about the (device name) is complete and accurate.
(Attach the summary of problem data, bibliography or other citations upon which the summary is based.) ___________________________
(Signature of Certifier)
___________________________
(Typed Name)
____________________________
(Date)
____________________________
*(Premarket Notification [510(k)] Number)
*For a new submission, leave the 510(k) number blank.
Must be signed by a responsible person of the firm required to submit the premarket notification [e.g., not a consultant for the 510(k) submitter].
z The name of the legally marketed (unmodified) device and the 510(k) number under which it was cleared. Include the trade or proprietary name, if any, and the common or usual name or classification
name of the device. Provide the classification of the device, approprate panel (e.g. cardiovascular, dental, etc.), and product code, if known.
In cases where the referenced 510(k) was submitted under a different name than that of the submitter of the Special 510(k), FDA recommends that a statement to this effect be included in the
Special 510(k) and that the submitter maintain adequate information demonstrating his legal right
to distribute the device.
When the legally marketed (unmodified) device is a preamendments device, the submitter should clearly state that the device is a preamendments device, is legally marketed, and has not
been the subject of premarket notification clearance. (Refer to "Documentation Required for
Preamendments Status" for the procedures for demonstrating preamendments status.) Submitters
should maintain this information in their files.
Preamendment Status
This guidance was written prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices, GGP’s. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be updated in the next revision to include the standard elements of GGP’s.
Preamendment Status
For purposes of documenting preamendment status in regard to intended use and commercial distribution, information provided must be adequate to document that the firm's preamendment device was labeled, promoted, and distributed in interstate commerce for a specific intended use. Please keep in mind that if this preamendment information is used to support a premarket notification (510(k)), then the specific intended use statements requested below should be the same as that proposed for the subject 510(k) device for which substantial equivalence is being sought. The Office of Device Evaluation (ODE) will provide input as to whether the specificity of the intended use statements are adequate if a 510(k) is involved.
FDA believes that submitters should be able to meet one of the following three scenarios (A, B, or C) in order to prove preamendment status of a device for a specific use. Below each italicized description of the scenario is the list of information required for that particular scenario.
A. The submitter is able to provide copies of documents that verify that the device was placed into
interstate commerce (for other than research uses or as part of a plant-to-plant transfer) and was
actually labeled and promoted for a specific intended use.
Provide dated copies of any available firm's advertisements, catalog pages, promotional material, journal article, manufacturing documents, and shipping documents (e.g., invoices, bills of lading,
receipts, etc.). FDA may also consider other pieces of information to address this item. Nevertheless,
the information provided (individually or collectively) must prove that there was interstate commerce
of the device and that the device was labeled and promoted for a specific intended use prior to May 28, 1976. Copies of any supporting information (e.g., journal article) must be provided, not just referenced.
In addition, any supporting information must reflect the device was not used as part of any research
study or for investigational use.
B. The submitter is not able to provide any of the information described in item A above.
1. Provide an affidavit from a current or former employee of the firm that distributed the device who
is, or was, in a position to be aware of the labeling and promotional information used for the device
and to attest that the device was distributed prior to May 28, 1976. This affidavit must include the
following:
z a statement explaining why any invoices or shipping records of pre-May 28, 1976
distribution are not available;
z detailed information relating to his/her position and how that placed he/she in a position to be aware of the preamendment labeling and promotion of the device;
z a statement that the device was not used as part of any research study or for investigational use prior to May 28, 1976;
z a statement, with any available supporting documentation, of the specific intended uses for which the device was labeled and promoted prior to May 28, 1976. Actual copies of any
supporting information (e.g., journal article) must be provided, not just referenced. Any
supporting information must not reflect the use of the device as part of any research study or
for investigational use prior to May 28, 1976; and
z a statement of his/her financial interest in the device or firm.
2. Provide an affidavit from a credible person who used the device prior to May 28, 1976. The
affidavit must include the following:
z a statement that the user has personal knowledge that the device entered interstate commerce prior to May 28, 1976;
z the name of the source and the state from which the device was shipped;
z a statement that the device was not received as part of any research study or for
investigational use prior to May 28, 1976;
z statement, with any available supporting documentation, of the specific intended uses for which the device was labeled and promoted prior to May 28, 1976. Actual copies of any
supporting information (e.g., journal article) must be provided, not just referenced; and z a statement of his/her financial interest in the device or firm.
Note: If it is not possible to obtain the affidavit for item B(1) above, then provide an affidavit documenting your efforts to obtain one, and provide affidavits from two credible users.
C. The submitter is able to provide only a portion of the information necessary to address item A
above. In this case, we may accept partial documentation from each of items A and B(1 and 2) above.
However, the submitter should attempt to address each item as complete as possible. Nevertheless, the collective documentation must, at minimum, address the key elements noted below.
1. Provide all partial documentation as described in item A above.
2. Provide the complete/partial affidavit from a current or former employee as described in item B(1)
above.
3. Provide the complete/partial affidavit(s) from a credible user(s) as described in item B(2) above.
Note: The key elements that must be addressed by the collective pool of documentation are:
z evidence of interstate commerce (for other than research uses or as part of a plant-to-plant transfer) prior to May 28, 1976;
z evidence of the specific intended use for which the device was labeled/promoted prior to May 28, 1976; and
z any affiant's financial interest in the device or firm.
All affidavits supplied must be notarized and include a statement concerning one's financial interest in the device or firm. Affidavits from individuals residing in other countries may be taken into consideration when accompanied with affidavits signed by persons residing in the U.S.
Preamendment device determination requests should be submitted using form FDA 3752 [PDF:
Pre-Amendment Device Determination Request].
Any questions relating to preamendment status should be addressed to the Office of Compliance at
301-796-5506.
z Items required under §807.87 (Information required in a Premarket Notification submission), including z description of the modified device; where applicable, photographs or engineering drawings should be supplied,
z comparison to the cleared device indicating similarities and/or differences accompanied by data, as appropriate; this information may include an identification of materials, design considerations,
energy expected to be used or delivered by the device, and a description of the operational
principles of the device.
z intended use of the device,
z proposed label, labeling, and advertisements for the device and directions for use. It is recommended that submitters of Special 510(k)s highlight, or otherwise prominently identify, all
changes in the proposed labeling that may result from modifications to their legally marketed
device. In addition, it should be clearly stated in the Special 510(k) that the intended use of the
modified device, as described in its labeling, has not changed as a result of the modification(s).
Please note that a labeling change from prescription use to over the counter use, or vice versa, is
considered a change in intended use and, therefore, is not eligible for the Special 510(k) method.
z A concise summary of the design control activities. FDA may consider the information generated from these activities to be "appropriate supporting data" within the meaning of §807.87(g). This summary
should include the following:
z An identification of the Risk Analysis method(s) used to assess the impact of the modification on the device and its components as well as the results of the analysis;
z Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and the acceptance criteria applied; and
z A declaration of conformity with design controls. (See Attachment 2 of 510(k) Paradigm) Please note that if a recent Quality System inspection has resulted in the issuance of a violative inspection
report, the manufacturer should be prepared to describe those corrective actions taken, if needed,
that form the basis for the declaration of conformity.
The declaration of conformity should include:
z A statement that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined
acceptance criteria were met; and
z A statement that the manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. If a recent
Quality System inspection has resulted in the issuance of a violative inspection report, the
manufacturer should be prepared to describe those corrective actions taken, if needed, that form the
basis for the declaration of conformity.
The above two statements should be signed by the designated individual(s) responsible for those
particular activities.
z Information on sterilization, biocompatibility, expiration date, etc., if applicable.
Tabs may be used to separate each section but in any case each section should begin on a new page. The order in which required elements are presented is less important than completeness. In other words, it is not strictly required that labeling be presented as part of the device specifications, or in a separate section. For additional information, see Content of a 510(k) and Format of a 510(k).
An example of a Special 510(k) can be found in Frequently Asked Questions on the New 510(K) Paradigm.
Where to Submit a 510(k)
A 510(k) should be put in a temporary, inexpensive binder. DO NOT permanently bind the application. FDA will take the submission out of whatever binding in which it was submitted, 3-hole punch the left margin, and put the 510(k) in a 3-ring "jacket" for review. Paper size should be 8.5 inches by 11 inches.
You must submit two copies of your 510(k) to the address below. One of your two copies may be submitted in electronic format
[https://www.doczj.com/doc/dc12356417.html,/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmis sions/ucm134508.htm]. FDA does NOT return the 510(k) submission after review. You should retain a copy of your 510(k) for your records. Submissions should be sent to:
Food and Drug Administration *
Center for Devices and Radiological Health
Document Mail Center - WO66-G609
10903 New Hampshire Avenue
Silver Spring, Maryland 20993-0002
* If your device is reviewed by CBER, send your 510(k) to directly to CBER
[https://www.doczj.com/doc/dc12356417.html,/AboutFDA/CentersOffices/CBER/default.htm] to avoid delays. The list of devices reviewed by CBER is available on Devices Regulated
[https://www.doczj.com/doc/dc12356417.html,/BiologicsBloodVaccines/DevelopmentApprovalProcess/510kProcess/ucm133429.ht m] by CBER.
We recommend that you send your 510(k) to FDA by a method that will provide a signed receipt of delivery, e.g., registered mail with a return receipt or a commercial delivery service. You should receive an acknowledgment letter from FDA, including the assigned 510(k) number, within two weeks of delivery. If after 2 weeks you have not received the 510(k) acknowledgement letter, contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) for assistance. 510(k) Submission Process describes the review process after the submission is received by FDA.
Traditional, Special, and Abbreviated 510(k)s require the same 510(k) review fee. Do NOT send the fee with the application. Information on how to submit the review fee can be found at 510(k) Review Fees [https://www.doczj.com/doc/dc12356417.html,/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmis sions/PremarketNotification510k/ucm134566.htm].
Frequently Asked Questions
1.Can FDA rely on a declaration of conformity for a substantial equivalence determination in a Special
510(k) if the manufacturer states that they will conform rather than they are in conformance?
A manufacturer may not state that it will conform to design controls at some future date, but rather
conformance must have already been determined at the time the application is submitted.
2.What advantage, if any, is there for a firm to use a third party to assess conformance with design
controls? If a firm does use a third party for the assessment, should this information be included in the 510(k) submission?
Many device manufacturers employ third parties in assessing conformance with design controls as
a matter of routine practice. Although it is ultimately the submitter's responsibility for assuring
conformance when electing to submit a declaration of conformity in a premarket submission, third party involvement may provide the manufacturer with added confidence when submitting a declaration and provide the FDA with additional assurance of conformance. Involvement by an independent, technically competent third party can only benefit the overall process.
FDA recommends that 510(k) submitters follow Attachment 2 in The New 510(k) Paradigm when preparing declarations of conformity to design controls. If a manufacturer uses a third party to perform a conformance assessment of design control requirements, the third party information should be
maintained in the firm's device master record (DMR).
3.What happens if the FDA determines that a Special 510(k) can not be reviewed as such? Is the
submission rejected? Is the review clock reset?
If the FDA determines that a Special 510(k) is not eligible for review as submitted, the reviewer will notify the firm of this decision and offer the option of having the document converted to a
Traditional 510(k) or withdrawing it for future submission. If the 510(k) is converted, the original
receipt date remains as the start of the review period. Manufacturers should be aware that, in most cases, additional information will be necessary for converted documents.
4.For Special 510(k)s, Attachment 2 of The New 510(k) Paradigm guidance document states that the
manufacturer's declaration of conformity should include a statement that "all verification and validation activities were performed. . . . " Since some of these activities are not usually performed until just prior to marketing, what activities should be performed prior to submission of the Special 510(k)?
This statement in the declaration of conformity is intended to capture the manufacturer's compliance with those verification and validation activities that are related to the design modification(s).
Therefore, prior to submission of a Special 510(k), FDA would expect that the verification and
validation activities, as identified by the risk analysis to ensure that the modified device is as safe and effective as the predicate device, would be completed and would demonstrate that the predetermined acceptance criteria had been met. In accordance with the Quality System Regulation, however, all
process validation must be completed and appropriately documented before commercialization of the device.
5.If a firm obtains clearance for a Special 510(k), will the firm necessarily be inspected to verify
conformance with design controls?
No. The Office of Compliance is developing an audit program to help determine if firms that submitted Special 510(k)s were in fact in conformance with design control requirements. This does not mean, however, that all firms that submit Special 510(k)s will be audited. Under the pilot program, a limited number of cleared submissions will be identified for verification of conformance with design controls by inspection. If a firm is to be inspected, FDA will notify the firm ahead of time and follow established GMP inspection procedures. However, please note that routine GMP inspections for Class II and III devices are required by the statute. Thus, submitters of 510(k)s for such devices are subject to inspection whether the premarket notification is submitted for review as an Abbreviated, a Special, or a Traditional 510(k).
6.For Special 510(k)s that were submitted but later determined to be ineligible for review as such, what
were the most common reasons for this determination?
The most frequently observed problem with Special 510(k)s has been related to the design control information that was submitted in support of the device modification. Several submissions did not
include a complete declaration of conformity to design controls. Other submissions included a statement indicating that the firm would comply with the design control requirements rather than a statement that the firm is in conformance. In a few 510(k)s, it was determined that the firm did not perform a complete risk analysis for the device modification.
Finally, one of the other problems observed with the Special 510(k)s that have been submitted for review has been related to the device modification that is the subject of the submission. As discussed in the Guidance, changes to the intended use and fundamental scientific technology should be submitted as Abbreviated or Traditional 510(k)s rather than as Special 510(k)s. Several of the Special 510(k)s that
were submitted included a change to either the intended use or to the fundamental scientific technology.
References
A New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications [PDF: The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance]
Frequently Asked Questions on the New 510(k) Paradigm [PDF: Guidance for Industry：Frequently Asked Questions on the New 510(K) Paradigm]
Do It By Design - An Introduction to Human Factors in Medical Devices [PDF: Do It By Design - An Introduction to Human Factors in Medical Devices]
Design Control for Manufacturers [PDF: Design Control Guidance For Medical Device Manufacturers]
DEPARTMENT OF HEALTH AND HUMAN SERVICES M E M O R A N D U M Food and Drug Administration Office of Device Evaluation 9200 Corporate Boulevard Rockville, MD 20850 Premarket Notification [510(k)] Review Traditional/Abbreviated K______________ Date: The Record Office: To: From: Division: 510(k) Holder: Device Name: Contact: Phone: Fax: Email: I. Purpose and Submission Summary The 510(k) holder would like to introduce (device name) into interstate commerce. II. Administrative Requirements Yes No N/A Indications for Use page (Indicate if: Prescription or OTC) Truthful and Accuracy Statement 510(k) Summary or 510(k) Statement Standards Form III. Device Description Yes No N/A Is the device life-supporting or life sustaining? Is the device an implant (implanted longer than 30 days)? Does the device design use software? Is the device sterile? Is the device reusable (not reprocessed single use)? Are “cleaning” instructions included for the end user?
510(K)注册 510(k)注册 FDA510（K）即上市前通告（Pre-market Notification），旨在证明该产品与已经合法上市的产品实质性等同（Substantially Equivalent）。因其相应FD&C Act第510（K）章节故通常称510（K）。因此FDA510（K）并不是产品【信息咨询】，而是产品注册。 1、根据FDA有关规定合适需申请510（K）： 1）首次将一种医疗器械引入美国市场进行销售的医疗器械制造商；Manufacturers of medical devices who would introduce a kind of medical devices in . market for the first time. 2）是再次向美国市场引入其改变或更新的医疗器械进行销售的制造商（这种变更或更新会影响器械的安全或有效性，这种改变或更新包括设计、材料、化学成分、驱动力、生产流程或者预期用途）。 实质性等同（SE）的含义：证明所申请上市的产品和已在美国市场上合法销售的产品在安全性和有效性方面比较是实质相等的。 1）与已上市的产品预期用途相同；产品的新特性不会对安全性或有效性产生影响，或者对安全有效性产生影响的新特性有可接收的科学方法用于评估新技术的影响以及有证据证明这些新技术不会降低安全性或有效性。 2）选择合适的产品进行比较是510（K）申请中实质性等同的关键步骤。实质性等同代表要素件表1。需要特别关注：510（K）申请时很少需要临床试验结果（Results from Human Clinical Studies），并且由申请方自行决定是否提交临床资料。 3）申请方必须提供充足的资料证明，所申请上市的器械和被比较的器械是实质性等同的，否则510（K）申请不会通过。
PROFESSIONAL SERVICE PROPOSAL BETWEEN REGULATORY COMPLIANCE SOLUTIONS, LLC And HuBei Weil Kang Protective Products Co, LTD Regulatory Compliance Solutions, LLC (RCS) is pleased to be able to contribute to HuBei Weil Kang Protective Products Co, LTD planned medical device product commercialization efforts and has made a genuine attempt to provide meaningful and realistic cost estimates. Services: Regulatory Guidance and Project Management RCS will provide routine correspondences as to the status of the project via teleconference or email. 1. 510K Review and Advisory Assessment A) Review existing 510K submission and all FDA correspondences. i.FDA Interaction – Limit to 1 or 2 calls 1.Identify the next steps. B) Provide information to client and discuss next steps. 2. Revision of the Present 510K Submission and Interaction with FDA. A) Prepare revised 510K. 3. Prepare a New 510K Submission and Interaction with FDA. A) Prepare 510K. 4. FDA Site Readiness Assessment 1
FDA医疗器械510K申请文件介绍 1．510(K)文件也即FDA对PMN所需的文件，因其相应FD&C Act第510章节，故通常称510（K）文件。对510（K）文件所必须包含的信息，FDA有一个基本的要求，其内容大致如下16个方面： 1）申请函，此部分应包括申请人（或联系人）和企业的基本信息、510（K）递交的目的、申请上市器械的名称型号和分类资料、进行实质等效比较的产品（Predicate Device）名称及其510（K）号码； 2）目录，即510（K）文件中所含全部资料的清单（包括附件）； 3）真实性保证声明，对此声明，FDA有一个标准的样本； 4）器材名称，即产品通用名、FDA分类名、产品贸易名； 5）注册号码，如企业在递交510（K）时已进行企业注册，则应给出注册信息，若未注册，也予注明； 6）分类，即产品的分类组、类别、管理号和产品代码； 7）性能标准，产品所满足的强制性标准或自愿性标准； 8）产品标识，包括企业包装标识、使用说明书、包装附件、产品标示等； 9）实质相等性比较（SE）； 10）510（K）摘要或声明； 11）产品描述，包括产品的预期用途、工作原理、动力来源、零组件、照片、工艺图、装配图、结构示意图等； 12）产品的安全性与有效性，包括各种设计、测试资料； 13）生物相容性； 14）色素添加剂（如适用）； 15）软件验证（如适用）； 16）灭菌（如适用），包括灭菌方法的描述、灭菌验证产品包装和标识等。 2．实质相等性比较（SE） 实质相等性比较是要证明所申请上市的产品和已在美国市场上合法销售的产品在安全性和有效性方面比较是实质相等的。选择合适的产品进行比较是510（K）申请的关键步骤。在进行比较时应从如下方面进行考虑：
美国FDA医疗器械510(k)深度分析系列一 中国对美国的医疗器械出口数量逐年增长，越来越多的中国企业需要面对美国食品与药品监督管理局FDA的审核。对于高风险的医疗器械，通常需要向美国FDA提交510(k)申请(也叫上市前通知)，在获得510(k)批准以后，方可销售到美国。 往往510(k)申请是企业需要面对的一大难题。相比CE认证，美国FDA 510(k)认证显的更加灵活、往往企业遇到的困难更大。在全面深入理解美国FDA相应法规要求的基础上，对美国FDA 510(k)历年申请情况进行全面的分析和总结是非常有必要的。针对这种情况，美国美德思国际医疗器械咨询机构(MEDevice Services, LLC)在参考众多资料并结合其多年来积累的FDA 510(k)丰富经验，对历年510(k)进行了系统总结和归纳。 上图显示了美国FDA从1976年到2009年中每一年收到的510(k)申请数量。从图中可以看出，80年代末和90年代初510(k)的申请达到了高峰(每年6000-7000件申请)，之后出现缓慢下降，近几年处于比较平稳的状态(每年接近4000件申请)。我们从这些数字可以看出当时美国FDA关于510(k)的一些政策变化。 1989年的510(k)申请有非常显著的增加，这种增加最主要是由于FDA对检查类手套从510(k)豁免变成了非豁免要求所造成的。这个法规要求变化以后，美国FDA一时间收到了超过1000件的已经投入市场的检查类手套510(k)申请。 510(k)申请数量在90年代下降的原因是FDA豁免了大部分的一类医疗器械以及1997年通过的食品药品管理局现代化法(FDAMA)让几十种二类医疗器械获得了510(k)豁免。 为了进一步对美国FDA工作量进行管理以及更加合理的分配资源，美国政府对于那些不需要符合上市前通知要求即可保证安全性和有效性的一类医疗器械产品进行了510(k)豁免。 在这个背景下，在1976年通过的医疗器材修正案(Medical Device Amendments)和1997年通过的食品药品管理局现代化法(FDAMA)期间，美国FDA 一共对574个一类医疗器械产品豁免了
传统和简略的510（k）文件的格式 该文件发布于2005年8月12日 序言 公共评论 起草的评论和建议可在任何时间提交给FDA，5630Fisher Lane，1061房间，Rockville，MD，20852。当提交评论时，请注明准确的文件标题。直到该文件被修改或升级时，该评论才会被实施。 另外的副本 另外的副本可从互联网中获取： https://www.doczj.com/doc/dc12356417.html,/cdrh/oivd/guidance/1567.pdf 或拨打301-827-0111。拨1进入系统，在第二声提示的时候，拨1或索要文件。 本指南是代表FDA现时在问题焦点的想法。它没有产生或赋予任何人权利，并且没有在约束FDA和大众的情况下运行。若该方法满足适用的条例、法规或两者的要求，则可使用该方法。若您想讨论使用其他方法，直接联系FDA实施该指南。若您未找到FDA，呼叫本指南中的电话。 简介 本文件的主要观点是如何规范原始的510（k）文件。 本指南仅提供了一个大体的组织框架和传统或简略510（k）文件的内容。这并不代表我们的建议对任何型式1的设备，特殊510（k）文件或其他型式文件，例如上市前许可申请（PMAs）或研究器械豁免申请。（IDEs） FDA认为该指南中的建议性文件能够保存FDA和企业资源定期审核。本指南补充其他FDA 指南中的510（k）程序和特殊设备类型，不是一个代替文件。 另一种方法，你可以提交协调格式的，该文件在“医疗器械安全和性能基本原理论证一致性的技术文件”中进行了描述，或在STED草案文件中找到。找CDRH网站关于设备特殊指南，网址https://www.doczj.com/doc/dc12356417.html,/scripts/cdrh/cfdocs/cfggp/search.cfm 特殊510（k）文件的选项允许申请者澄清他们本国法规上市的医疗器械并且没有影响改设备预期使用的变化。见https://www.doczj.com/doc/dc12356417.html,/cdrh/ode/parad510.html。 包容不具约束力的建议 FDA指南，对提议全球一致性的预上市程序进行全面评估的试点项目，对FDA试点程序和适宜型号的指南。 若你想以STED格式提交510（k）文件，本文件中关于传统510（k）的信息可帮助你准备STED提交。附录C给出了本指南推荐章节和STED格式的关联。 FDA指南文件，包括本指南，未建立法规上可实施的责任。相反，指南描述代理处当前的思考的焦点和应视为一个建议，除非法规要求建立。在指南文件中的“should”代表建议做的事情，不是必须要求。 最低繁琐的方法 我们认为我们是在设备法规的所有领域内考虑最低繁琐的方法。该指南反映出我们关于科学和犯规的慎重观点，以及与那些要求一致的最低繁琐方法。然而，若您认为还有别的方法更简便，请联系我们。你可以发送文本评论到序言中提到的联系人或CDRH政府官员。关于这些信息可从https://www.doczj.com/doc/dc12356417.html,/cdrh/ombudsman/。 背景 本文件支持其他FDA关于510k文件提交的内容要求。你可参考E节CFR807，21号法规和网站https://www.doczj.com/doc/dc12356417.html,/cdrh/devadvice/314.html中的how to prepare a 510k submission。
SCREENING CHECKLIST FOR ALL PREMARKET NOTIFICATION [510(k)] SUBMISSIONS 510(k) Number: ________________ The cover letter clearly identifies the type of 510(k) submission as(Check the appropriate box): Special 510(k) - Do Sections 1 and 2 Abbreviated 510(k) - Do Sections 1, 3 and 4 Traditional 510(k) or no identification provided - Do Sections 1 and 4 Section 1: Required Elements for All Types of 510(k) submissions: Present or Adequate Missing or Inadequate Cover letter, containing the elements listed on page 3-2 of the Premarket Notification [510)] Manual. Table of Contents. Truthful and Accurate Statement. Device’s Trade Name, Device’s Classification Name and Establishment Registration Number. Device Classification Regulation Number and Regulatory Status (Class I, Class II, Class III or Unclassified). Proposed Labeling including the material listed on page 3-4 of the Premarket Notification [510)] Manual. Statement of Indications for Use that is on a separate page in the premarket submission. Substantial Equivalence Comparison, including comparisons of the new device with the predicate in areas that are listed on page 3-4 of the Premarket Notification [510)] Manual. 510(k) Summary or 510(k) Statement. Description of the device (or modification of the device) including diagrams, engineering drawings, photographs or service manuals. Identification of legally marketed predicate device. * Compliance with performance standards. * [See Section 514 of the Act a nd 21 CFR 807.87 (d).] Class III Certification and Summary. ** Financial Certification or Disclosure Statement for 510(k) notifications with a clinical study. * [See 21 CFR 807.87 (i)] 510(k) Kit Certification *** * - May not be applicable for Special 510(k)s. ** - Required for Class III devices, only. ***- See pages 3-12 and 3-13 in the Premarket Notification [510)] Manual and the Convenience Kits Interim Regulatory Guidance.
如何准备医疗器械510（K）申请文件 1．510(K)文件也即FDA对PMN所需的文件，因其相应FD&C Act第510章节，故通常称510（K）文件。对510（K）文件所必须包含的信息，FDA有一个基本的要求，其内容大致如下16个方面： 1）申请函， 2）目录， 3）真实性保证声明； 4）器材名称； 5）注册号码； 6）分类； 7）性能标准； 【其余内容从略，详情请与我司联系】 2．实质相等性比较（SE） 实质相等性比较是要证明所申请上市的产品和已在美国市场上合法销售的产品在安全性和有效性方面比较是实质相等的。选择合适的产品进行比较是510（K）申请的关键步骤。在进行比较时应从如下方面进行考虑： 【内容从略，详情请与我司联系】 企业必须提供充足的资料证明，所申请上市的器械和被比较的器械是实质相等的（SE），否则510（K）申请不会通过。 3．510（K）审查程序 FDA在收到企业递交的510（K）资料后，首先检查资料是否齐全，如资料齐全，则受理并给企业发出确认性，同时给出申请受理编号（K YYXXXX），此号码也将作为正式批准后的号码；如不齐全，则要求企业在规定时间内补充齐全，否则作企业放弃处理。FDA在受理申请
后即进入内部工作程序，其中可能还会要求企业补充一些资料。在510（K）申请通过审阅后，F DA并不立即发出批准函件，而是根据产品风险等级、市场先前是否对企业有不良反映等确定是否对企业进行现场GMP考核，考核通过后再发给企业正式批准函件（Clearance）；如无须现场考核GMP，则510（K）申请通过后立即发给正式批准函件。 向FDA申请时需注意的一些问题 1．在申请前必须明确产品是否被FDA认作医疗器械、产品类别、管理要求，明确申请工作内容； 2．对申请上市的产品查阅有否美国强制标准，产品是否符合该标准 3．在准备510（K）申请文件前，需考虑是否真正需要递交、何时递交以及递交哪一种性质的510（K）申请：常规510（K）、特殊510（K）、简化510（K）； 4．对申请过程中FDA所提出的问题应及时给予书面的、及时的回答； 5．向FDA递交的所有资料纸张大小应采用Letter Size（21.5cm X 29.7cm）； 6．所有递交FDA的资料企业需留有备份，因为FDA在收到申请资料后即电子扫描登录，同时销毁申请资料，并不归还企业。 7．对少部分产品，FDA将对企业进行现场GMP考核，企业需参照美国GMP管理要求，并在FDA现场审核时配备合适的、对GMP和企业有一定了解的翻译人员； 8．告知FDA的正式联系人需对FDA法规和工作程序有一定的了解，并能与FDA直接交流，以方便及时反馈，企业可明确自己或委托咨询机构负责与FDA的日常沟通。
510(k)简介 为了在美国上市医疗器械，制造商必须经过两个评估过程其中之一：上市前通知书[510(k)]（如果没有被510(k)赦免），或者上市前批准 (PMA)。大多数在美国进行商业分销的医疗器械都是通过上市前通知书[510(k)]的形式得到批准的。在某些情况下，在1976年5月28日之前合法上市的器械，既不要求递交510(k)也 不要求递交PMA。 510(k)文件是向FDA递交的上市前申请文件，目的是证明申请上市的器械与不受上市前批准 (PMA)影响的合法上市器械同样安全有效，即为等价器械(substantially equivalent)。申请者必须把申请上市的器械与现在美国市场上一种或多种相似器械对比，得出并且支持等价器械的结论。合法上市器械是在1976年 5月28日之前合法上市的器械(preamendment device)，或者从III类器械中分入II或I类的器械，或者通过510(k)程序发现与这样的器械等价的器械，或者通过自动的III 类器械定义的评价建立的器械。与之等价的器械被称为“predicate device(s)”。申请者必须提交描述性的数据，必要的时候，要提交性能数据来说明器械是predicate device的等价器械。再次说明，510(k)的数据是显示相似性的数据，即，新器械与predicate device的等价程度。 FDA 等价器械 510(k)不像PMA那样要求合理的安全性和有效性的证明，而是要求等价器械的证明。等价器械就是新的器械与predicate device一样安全有效。 与predicate device相比，如果符合下列条件，就认为器械是等价器械： —与predicate device有相同的使用目的，具有相同的技术性能；或者 —与predicate device有相同的使用目的，具有不同的技术性能，但是并没有增加安全性和有效性的问题，并且证明人证明器械与合法上市器械一样安全有效。 所谓等价器械并不是说新的器械与predicate devices必须完全相同。等价器械是关于使用目的、设计、使用的或传送的能源、材料、性能、安全性、有效性、标注、生物相容性、标准和其他可应用的特征。 申请者在收到宣布为等价器械的指令之前，器械不得上市。一旦器械确定为等价器械，然后就可以在美国上市。如果FDA确定器械不是等价器械，申请者可以递交另一份含有新数据的510(k)文件，提出重新分类请求，或者递交上市前批准申请(PMA)。通常在90天内，基于申请者递交的信息，得出等价器械的结论。 谁必须递交510(k) 食品、药品和化妆品(FD&C)行动委员会和21 CFR 807的510(k)规章中并没有特别指出谁必须申请510(k)——任何人都可以申请。但是，他们指定了哪种行为，例如把器械引入美国市场，要求510(k)申请。 基于指定的行为，必须向FDA递交510(k)的如下所示：
医疗器械FDA注册流程 FDA对医疗器械的管理通过器械与放射健康中心（CDRH）进行的，中心监督医疗器械的生产、包装、经销商遵守法律下进行经营活动。 医疗器械范围很广，小到医用手套，大至心脏起博器，均在FDA监督之下，根据医疗用途和对人体可能的伤害，FDA将医疗器械分为Ⅰ、Ⅱ、Ⅲ类，越高类别监督越多. 如果产品是市场上不曾存在的新颖发明，FDA要求厂家进行严格的人体实验，并有令人信服的医学与统计学证据说明产品的有效性和安全性。 医疗器械的FDA认证,包括：厂家在FDA注册、产品的FDA登记、产品上市登记（510表登记）、产品上市审核批准（PMA审核) 医疗保健器械的标签与技术改造、通关、登记、上市前报告，须提交以下材料：（１）包装完整的产成品五份,（２）器械构造图及其文字说明,（３）器械的性能及工作原理；（４）器械的安全性论证或试验材料,（５）制造工艺简介,（６）临床试验总结,（７）产品说明书. 如该器械具有放射性能或释放放射性物质，必须详细描述. 医疗器械的工厂和产品注册 FDA对医疗器械有明确和严格的定义，其定义如下：“所谓医疗器械是指符合以下条件之仪器、装置、工具、机械、器具、插入管、体外试剂及其它相关物品，包括组件、零件或附件：明确列于National Formulary或the Unite States Pharmacopeia或前述两者的附录中者；预期使用于动物或人类疾病，或其它身体状况之诊断，或用于疾病之治愈、减缓与治疗者；预期影响动物或人体身体功能或结构，但不经由新陈代谢来达到其主要目的者”。 只有符合以上定义的产品方被看作医疗器械，在此定义下，不仅医院内各种仪器与工具，即使连消费者可在一般商店购买之眼镜框、眼镜片、牙刷与按摩器等健身器材等都属于FDA之管理范围。它与国内对医疗器械的认定稍有不同。 根据风险等级的不同，FDA将医疗器械分为三类（Ⅰ，Ⅱ，Ⅲ），Ⅲ类风险等级最高。FDA将每一种医疗器械都明确规定其产品分类和管理要求，目前FDA医疗器械产品目录中共有1，700多种。任何一种医疗器械想要进入美国市场，必须首先弄清申请上市产品分类和管理要求。 FDA针对医疗器械制订了许多法案，并不时地进行修改和补充，但根本的法案并不多，主要包括：联邦食品、药品与化妆品法案（FD&C Act，根本法案）；公众健康服务法案；公正包装和标识法案；健康和安全辐射控制法案；安全医疗器械法案；现代化法案。对这些法案，FDA给予了非常详细的解释，并配套有具体的操作要求。企业在计划进入美国市场前，需仔细评估针对自己产品相关的法规和具体要求（包括不同的美国产品标准要求）。 在明确了以上信息后，企业就可以着手准备有关的申报资料，并按一定程序向FDA申报以获取批准认可。对于任何产品，企业都需进行企业注册（Registration）和产品列名（Listing）。对Ⅰ类产品（占47%左右），实行的是一般控制（General Control），绝大部分产品只需进行注册、列名和实施GMP规范，产品即可进入美国市场（其中极少数产品连GMP也豁免，极少数保留产品则需向FDA递交510（K）申请即PMN（Premarket Notification））；对Ⅱ类产品（占46%左右），实行的是特殊控制（Special Control），企业在进行注
510(K) 安全性和有效性总结 申请人：泰科医疗集团全球业务外科器械部（经营名称：柯惠）， 米德尔顿大道60 北哈芬，康乃狄克06473 电话：(203)492-5352 联系人：Frank Gianelli 项目经理，注册专员 准备日期：2009.10.29 商品名/专有名：Autosuture TM腔镜下切割吻合器及一次性钉匣 通用名/常用名：可植入钉匣切割吻合器 器械分类名称：钉匣，可植入 参照器械：Autosuture TM腔镜下切割吻合器(K083519;K061095) 产品描述：此510(K)展示了一种新型三排钉钉仓，可用于市面上 Autosuture TM腔镜下切割吻合器，产品描述参照材料 K083519。黑色钉仓除在超厚组织中建议钉高大小为 4.0,4.5, 5.0mm外，其他与参照材料中的三排钉钉仓组件具有 完全相同的设计特征。黑色钉仓组件建议长度为45mm和 60mm。 适用范围：Autosuture TM腔镜下切割吻合器适用于腹部、妇产、小儿以 及胸部外科手术中组织的切除、横断和吻合。也可用于肝脏 实质、肝脏血管和胆囊管道的切除和横断。 注：腔镜下切割吻合器及一次性钉匣适用于腔镜下切割吻合 器，吻合器不附单独说明。 技术特征：应用于超厚组织的腔镜下切割吻合器及一次性钉匣与基于 吻合器技术的钉仓本质相同。此外，在超厚组织切除和横断 时，一次性黑色三排钉钉仓可以为外科医生提供additional offering. 材质：A utosuture TM腔镜下切割吻合器及一次性钉匣的所有零部件 材料符合ISO 10993-1 性能参数：测试与体内性能评估表明，腔镜下切割吻合器及一次性钉匣 在与Autosuture TM腔镜下切割吻合器配合使用时是安全有 效的，符合适用范围。