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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
Purpose
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.
Background
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."
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
decision;
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?
(ANY NO ANSWER NEEDS AN EXPLANATION ATTACHED)
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: ________________________________________________________
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