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Premarket Notification - Consistency of Reviews #K89-1 (Blue Book Memo) February 1989

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

510(k) Memorandum #K89-1

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.

February 28, 1989

510(k) Memorandum #K89-1

Premarket Notification - Consistency of Reviews


    This guidance document outlines methods for identifying important 
    issues that require uniform treatment across the divisions of the 
    Office of Device Evaluation, for developing guidance on these issues,
    and for ensuring proper implementation in the review of premarket 
    notifications (510(k)) for the purpose of achieving a high level of 
    consistency in the review process.


    At the request of Congressman Henry Waxman, the United States General 
    Accounting Office (GAO) conducted an extensive review of FDA's 
    implementation of the premarket notification (510(k)) program.  GAO was 
    asked to identify any problems pertaining to both formal policies and 
    the day-to-day operations of the program.

    GAO first contacted FDA in October, 1986 to schedule an entry 
    conference for the purpose of explaining what the study would 
    encompass.  The study continued until November, 1987 and the final GAO 
    report to Congressman Waxman issued on September 21, 1988.

    The final GAO report identified areas where improvement to the program 
    could be made and included specific recommendations to Congress, the 
    Department of Health and Human Services, and FDA.  GAO recommended that 
    FDA develop a mechanism to improve consistency of 510(k) reviews.  In 
    response to these recommendations, the ODE division directors met, 
    discussed, and developed the guidance below.


    A.  Documentation:  The Premarket Notification Coordinator will develop 
        guidance for the documentation of all 510(k) reviews, which will 
        prompt the reviewer for answers to questions critical to decisions 
        of substantial equivalence and critical to consistent applications 
        of ODE guidance.  Further, the guidance will prompt the reviewer to 
        refer to other guidance documents in areas where ODE has 
        established crosscutting guidance (e.g., toxicology, software, 
        sterilization, etc.).
    B.  Crosscutting issue identification:  At monthly management meeting 
        of the ODE senior staff, time will be allotted for the specific 
        purpose of identifying important issues that require uniform 
        treatment.  These issues may be scientific, regulatory, or
        administrative.  Division directors will solicit input on important 
        issues for consideration from their branch chiefs and staffs on a 
        routine basis.  The Premarket Notification Coordinator will also be 
        responsible for identifying important crosscutting issues for 
        consideration.  Monthly     meetings of all ODE branch chiefs will 
        serve as another vehicle for identifying crosscutting issues and 
        bringing them to the attention of ODE management.  Identification 
        of important issues will be based on personal observation, review 
        of premarket notification decisions and supporting documentation, 
        input from Center committees, input from outside organizations and 
        special studies conducted at the request of the Director, ODE.

    C.  Implementation of new guidance procedures:  When it is determined  
        that new guidance is needed, they will be developed and  
        disseminated by means such as: 
        1.  Blue book memoranda;

        2.  Memoranda to review staff;

        3.  Senior management meetings with review staff;

        4.  Training sessions or workshops for supervisors
            and review staff; and

        5.  Other activities as deemed appropriate.

    D.  Monitoring the implementation:   The division directors and branch 
       chiefs have responsibility for monitoring the implementation of new 
       guidance within their respective organizations.  The Premarket 
       Notification Coordinator will monitor implementation across the 
       divisions of ODE.  The monthly senior staff management meetings and 
       branch chief meetings will provide additional, informal 
       opportunities for monitoring.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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