Medical Devices

IDE Refuse to Accept Procedures #D94-1 (blue book memo) (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.

IDE Memorandum #D94-1

         Deputy Director, Office of Device Evaluation (HFZ-400)
         IDE Refuse to Accept Procedures
         ODE Review Staff
         The purpose of this memorandum is to establish procedures under which 
         an IDE that does not meet a minimum threshold of acceptability will not
         be accepted for substantive review and approval.
         The Office of Device Evaluation (ODE) receives approximately 225 
         original Investigational Device Exemptions (IDE) submissions each year.
         Many of these applications are incomplete or grossly inadequate, i.e., 
         they fail to contain information clearly required under the regulations
         and they fail to contain the components necessary to allow substantive 
         review.  An IDE application that is missing any of the elements of 21 
         CFR 812.20, is technically an incomplete application and, therefore, 
         not subject to the 30 day review clock.  As a means to employ ODE 
         resources more effectively, these procedures are being implemented to 
         ensure that IDEs meet a minimum threshold of acceptability; otherwise, 
         ODE will refuse to accept the application.  These procedures will 
         benefit both FDA and IDE sponsors.
         A primary goal in establishing these "Refuse to Accept Procedures" for 
         IDEs is to improve the use of our review resources by ensuring that 
         they are focused on the review of reasonably complete and well-
         supported applications.  Often, during initial substantive review, ODE 
         has found that crucial information necessary to make a decision to 
         approve or disapprove an IDE has been omitted.  When making a decision 
         to accept or not to accept an application, ODE will identify those 
         applications in which sufficient information is submitted to allow a 
         decision on the approvability of the investigation (i.e., the 
         application is complete on its face).  By establishing these procedures
         with criteria for completeness of an application that are clear, 
         consistent, and available to sponsors, they will know what is 
         expected of them for each submission and device they intend to 
         investigate.  Sponsors will be likely to comply with the established 
         criteria to speed the time to substantive review of and a final 
         decision on their application.

         These procedures are based upon the Management Action Plan (MAP) 
         initiative issue paper entitled "Center for Devices and Radiological 
         Health's Investigational Device Exemptions (IDE) Refuse to Accept 
         Policy."  This Blue Book Memorandum embodies the guidance procedures 
         flowing from that issue paper and hereby replaces that document as the 
         policy of ODE.  Attached to the MAP issue paper was a document entitled
         "IDE Refuse to Accept Criteria" and an accompanying checklist.  As 
         described below, these criteria and the checklist will be used by ODE 
         reviewers in applying these guidance procedures to the review of 
         incoming IDEs.
         In general, there are three bases for refusal to accept an IDE:
              1.  An approved IDE is not required for the investigation.
              2.  The application omits a section of the IDE required under 
                  the IDE regulation, 21 CFR Part 812.
              3.  The application fails to address generally accepted scientific
                  and professional principles governing the conduct of clinical 
                  trials or scientific/technical issues clearly described in 
                  general, device-specific, and crosscutting guidance documents 
                  made publicly available by FDA.
         The checklist that accompanies the "IDE Refuse to Accept Criteria" is a
         general checklist.  Divisions may modify or supplement this general 
         checklist based on available guidance documents appropriate to their 
         specific device areas.  Division guidance documents should be 
         promulgated wherever needs are identified.  Guidances should provide 
         specific details about what is expected and acceptable for all 
         components of the submissions.  Each product specific guidance should 
         include a checklist to be used by a) the applicant in preparing the 
         submission and b) reviewers during the initial evaluation to consider 
         accepting the application for full review.  Checklists should also be 
         prepared for existing guidelines.  This will save time and provide 
         consistency across submissions.  Also, emphasis should be placed on 
         improved communication with industry.
         In addition to the copies that are being made available to ODE 
         reviewers, the document, "IDE Refuse to Accept Criteria" and any device
         specific guidance documents and checklists developed by the divisions 
         are being made available to manufacturers and other members of the 
         public by the Center's Division of Small Manufacturers Assistance.

         This guidance memorandum will be implemented by the review divisions 
         within the Office of Device Evaluation utilizing the following 
         procedures.  The specific timeframes are goals that will be met to the 
         extent permitted by available resources.

         1.   Processing
              a.  The ODE Document Mail Center (DMC) will log in and jacket the 
                  IDE and forward it to the IDE Staff.  The IDE Staff will 
                  conduct a preliminary review to verify that the submission is 
                  an IDE, and that it is administratively complete.  If grossly 
                  administratively incomplete, the IDE Staff will issue an 
                  incomplete letter.  If the submission is administratively 
                  complete, it will be forwarded to the appropriate review 
                  division within 2 days of receipt of the application in the 
                  DMC or as quickly as available resources allow.
              b.  A designated reviewer (Branch Chief, Reviewer, CSO, CST), 
                  using the IDE Refuse to Accept Criteria and checklist, and 
                  other appropriate device specific checklists, will determine 
                  whether the IDE is sufficiently complete to allow substantive 
                  review.  The division should consult with the Program 
                  Operations Staff (POS) on any decision that is particularly 
                  difficult or controversial.
              c.  Refuse to Accept recommendation(s) will be forwarded to the 
                  appropriate supervisor for concurrence within 10 days of DMC's
              d.  If an application is found to be sufficiently complete to 
                  allow substantive review, the IDE will be placed into the 
                  queue for substantive review.
              e.  If an application is found to be insufficiently complete to 
                  allow substantive review, a Refuse to Accept letter will be 
                  prepared, in coordination with the POS Staff, for the Division
                  Director's signature.  The Refuse to Accept letter, detailing 
                  the omissions or inadequacies that led to the decision not to 
                  accept the application, will issue within 15 days of receipt 
                  of the original IDE.  The letter will clearly state whether a 
                  complete, new application must be submitted or specify which 
                  portion of the application must be provided if the sponsor 
                  wishes to pursue the investigation.
         2.   Industry Inquires
              In the event that the sponsor has questions regarding the Refuse 
              to Accept letter, the sponsor may contact the appropriate Division
              Director, via letter, telephone, or telefax, regarding the 

         3.   Monitoring
              The implementation of the IDE Refuse to Accept Procedures will be 
              reviewed by the Office of the Director, ODE, at regular intervals,
              approximately every 90 days, to determine the number of incomplete
              and/or inadequate applications not accepted, the consistency with 
              which the criteria are applied among and within divisions, further
              necessary refinements to the process, and the overall impact on 
              the IDE program.
         Effective Date
         This memorandum effective immediately.
                                             Susan Alpert, Ph.D., M.D.


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