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Medical Devices

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510(k) Quality Review Program (Blue Book Memo I96-1) (Text Only)

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.

Integrity Memorandum - #I96-1          

         Office of Device Evaluation (HFZ-400)
         510(k) Quality Review Program
         ODE Review Staff
         Through:  ODE Branch Chiefs
         This memorandum modifies the independent quality review system 
         established by Blue Book Memorandum I90-4 to enhance management and 
         scientific oversight of the premarket notification (510(k)) review 
         process and to further ensure the integrity and fairness of the process
         and the scientific propriety of the 510(k) decisions that are made.  
         This memorandum also rescinds and replaces memo I90-4.
         The Department of Health and Human Services (DHHS) Office of Inspector 
         General (OIG) in its report entitled, "Internal Control Weaknesses in 
         the Food and Drug Administration's Medical Device 510(k) Review Process
         (A-15-89-00065)," recommended "(e)stablishing a quality control review 
         system that involves an independent review of completed premarket 
         notification decisions by an FDA group either inside or outside of 
         ODE."  The Office of Device Evaluation concurred with this 
         recommendation, but pointed out that some mechanisms already exist to 
         ensure quality reviews, such as involvement of immediate supervisors in
         the review process for all 510(k)s and further involvement of the 
         Office of the Director, ODE, in the review of select categories of 
         final 510(k) decisions.  See Blue Book Memorandum #K94-2, "510(k) 
         Sign-off Procedures."  
         To implement this quality review system, the Office of Device 
         Evaluation will use the following procedures to review, on a quarterly 
         basis, a sampling of final 510(k) decisions.  
         1.  Selection of Documents for Review - The Chief, Premarket 
         Notification Section, will randomly select completed 510(k)s from the 
         previous review quarter that have been found to be Substantially 
         Equivalent (SE) or Not Substantially Equivalent (NSE) for a quality 
         review as set forth below.  The selection of 510(k)s will include 
         devices from class I, II and III and, if available, will be selected 
         from each classification panel designation, presently 18 in number.  At
         least nine 510(k)s will be selected for each quarter, representing up 
         to two 510(k)s from each panel designation per year.
         2.  510(k) Quality Review Panel - A 510(k) Quality Review Panel (QRP) 
         will be established to provide an impartial oversight function of the 
         510(k) review process.  The QRP will be comprised of all ODE Branch 
         Chiefs and representatives of other Center offices, as appropriate.  
         Each 510(k) being reviewed will be assigned to a Quality Review Team, a
         subgroup of the QRP, for initial screening.  The QRP will meet once 
         each quarter to review the quality of the screened 510(k)s.  The QRP 
         will be chaired by the Chief, Premarket Notification Section. 
         3.  510(k) Quality Review Team - The 510(k) Quality Review Team (QRT) 
         will be comprised of three members of the QRP but will not include the 
         Chief of the Branch that completed the review and made the SE or NSE 
         determination on the 510(k) being screened.  The QRT will conduct an 
         initial evaluation of the 510(k) assigned to it using the "510(k) 
         Quality Review Checklist" as set forth in Attachment A.  Upon 
         completion of the checklist, the 510(k) and the completed checklist 
         will be presented to the QRP for discussion.  The Chief of the Branch 
         that reviewed the 510(k) and issued an SE or NSE decision should be 
         prepared to answer questions, discuss the background, and provide 
         insight on the 510(k).  
         4.  Document Review Procedure -  The QRP will review each screened file
         and the accompanying checklist and reach a consensus on the following 
         principles, which are embodied in the checklist:   
             a. the correctness and consistency of the decision;
             b. the submission of the information and data necessary for the 
             c. the appropriateness and consistency of additional data requests 
                (i.e., requests for necessary and sufficient information);
             d. the adequacy of documentation in the administrative record for 
                the decision;
             e. the scientific correctness and the quality of the review and 
                ultimate decision; and,
             f. any other analysis or comments deemed relevant and material by 
                the QRP.
         5.  Summary of Findings - A summary of findings will be prepared for 
         each 510(k) reviewed at the conclusion of the QRP quarterly review 
         meeting.  The summary of findings will include a copy of the completed 
         checklist.  The specific findings with appropriate recommendations will
         be distributed to the ODE Integrity Officer, the Director, ODE, and, 
         when appropriate, to ODE Division Directors, for follow-up actions, 
         including corrective action, as necessary. 
         Effective Date 
         The QRP will be established and begin its review function during the 
         quarter beginning June 1, 1996.
                                    Susan Alpert, Ph.D., M.D.


Integrity Memorandum - #I96-1
                                                           Attachment A - Page 1
                              510(k) Quality Review Program
         Section 1 -- Background Information
         510(k) Number _______________   Date of Final Decision _______________
         Final Decision ______________   Product Code ______  Panel Code ______
         Device Name __________________________________________________________
         Class _________   Tier _________  Division _________  Branch _________
         Submitter ____________________________________________________________
         Section 2 -- Administrative Completeness
         Was the Memorandum of Record Complete:          Yes        No
         If "NO" Why Not? ____________________________________________________
         Section 3 -- Decision
         (Answer only those questions that were relevant to this 510(k))
         Was the basis for the basis for the decision on each item adequate for 
         the review/decision?
         1.  Same indication statement:                 YES        NO
         2.  Do the difference alter the effect
             or raise new issues of safety or
             effectiveness:                             YES        NO
         3.  Same technological characteristics:        YES        NO
         4.  Could the new characteristics affect
             the safety or effectiveness:               YES        NO
         5.  Descriptive characteristics precise
             enough to ensure equivalence:              YES        NO
         6.  New types of safety or effectiveness
             questions:                                 YES        NO
         7.  Accepted scientific methods exist:         YES        NO
         8.  Performance data available:                YES        NO
         9.  Data demonstrate equivalence:              YES        NO
         Section 4 -- Summary of Findings
         (To be filled out at the Quality Review Panel Meeting)
         Quality Review Team:  ________________________________________________
         Was there an adequate basis for the overall scientific decision?
                                                        YES        NO
         If "NO" why not?  (See Blue Book Memo K86-3)
         Section 5 -- Follow-up
         Issues Requiring Follow-up (please list):
         Disposition of Issues:
         Reviewed by:  ________________________________________________________