Blue Book Memo - 510(k) Refuse to Accept Procedures

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.

Updated May 7, 1997

horizonal rule

Center for Devices and Radiological Health / CDRH