510(k) Refuse to Accept Procedures #K94-1 (blue book memo) (Text Only)

510(k) Memorandum #K94-1

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.

May 20, 1994

510(k) Memorandum #K94-1
    
 Acting Director,  Office of Device Evaluation (HFZ-400)
 
 510(k) Refuse to Accept Procedures
  
 ODE Review Staff
 
 
 Purpose
 
 The purpose of this memorandum is to establish procedures under which a 
 510(k) that does not meet a minimum threshold of acceptability will not 
 be accepted for substantive review and clearance.
 
 Background
 
 The Office of Device Evaluation (ODE) receives approximately 6500 
 Premarket Notification (510(k)) submissions every year.  Many of these 
 submissions are incomplete or grossly inadequate, as they fail to 
 contain the components necessary to allow substantive review of the 
 submission.  As a means to employ ODE resources more effectively, these 
 procedures are being implemented to ensure that 510(k)s meet a minimum 
 threshold of acceptability; otherwise, ODE will refuse to accept the 
 submissions for substantive review.  These procedures will benefit both 
 FDA and submitters.
 
 A primary goal in establishing these "Refuse to Accept Procedures" for 
 510(k) submissions is to improve the use of our review resources by 
 ensuring that they are focused on the review of reasonably complete and 
 well-supported submissions.  It is critical to distinguish between the 
 completeness of the regulatory submission and the quality of the 
 data provided and any studies conducted in support of the submission.  
 These procedures are not intended to mean that ODE should only be 
 expending resources in the review of submissions for devices that, on 
 their face, may be substantially equivalent to a legally marketed 
 predicate device.  However, after the initial 510(k) review, the Center 
 will often find that additional data or information is necessary before 
 the reviewer can determine whether the device is substantially 
 equivalent.  A decision to refuse to accept a 510(k) will be based on 
 omission of clearly necessary information.  By establishing these 
 procedures, with criteria that are clear, consistent, and available to 
 submitters, they will know what is expected of them for the particular 
 submission.  Submitters will be likely to comply with the established 
 criteria to speed the time to substantive review and regulatory 
 decision.

 The procedures will benefit both FDA and submitters.  These 
 procedures are based upon the Management Action Plan (MAP) initiative 
 issue paper entitled "Center for Devices and Radiological Health's 
 Premarket Notification (510(k)) 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 "510(k) Refuse 
 to Accept Criteria" and an accompanying checklist.  As described below, 
 criteria and the checklist will be used by ODE reviewers in applying 
 these guidance procedures to the review of incoming 510(k)s.
 
 Divisions may supplement the 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 submitter in preparing the submission and b) reviewers during the 
 initial evaluation to consider accepting the submission 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.
 
 The document, "510(k) 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.
 Procedures
 
 This guidance memorandum will be implemented by the review divisions 
 within the Office of Device Evaluation utilizing the following 
 procedures.  The specified 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, jacket, and 
           distribute the 510(k) to the appropriate review division with  
           the 510(k) Refuse to Accept Checklist and documentation forms 
           within 5 days of receipt in the DMC or as quickly as 
           available resources allow.
 
      b.   A designated reviewer (Branch Chief, Reviewer, CSO, CST) 
           using the 510(k) Refuse to Accept Criteria and checklist, and 
           other appropriate device specific checklists, will determine 
           whether the 510(k) 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 21 days of 
           DMC's receipt.  
 
      d.   If the submission is found to be sufficiently complete to 
           allow substantive review, the 510(k) will be placed into the 
           queue for substantive review. 
 
      e.   If the submission 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 submission will issue within 30 
           days of receipt of the 510(k).  The letter will clearly 
           specify which portion of the submission must be provided if 
           the submitter wishes to pursue clearance for marketing.  
           Copies of pertinent guidance documents will be enclosed with 
           the Refuse to Accept letter.
 
 2.   Industry Inquires
 
      In the event that the submitter has questions regarding the Refuse 
      to Accept letter, the submitter may contact the appropriate 
      Division Director, via letter, telephone, or telefax, regarding 
      the decision.
 
 3.   Monitoring
 
      The implementation of the 510(k) 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 submissions 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 510(k) program.
 
 
 Effective Date
 
 This memorandum is effective immediately.
 
 
 
                                     Susan Alpert, Ph.D., M.D.