FDA Issues Draft Guidance and 510(k) Submission Checklist

Oct 29, 2012   

On August 13, 2012, the U.S. Food and Drug Administration (“FDA“) issued a Draft Guidance document entitled “Refuse to Accept Policy for 510(k)s” (“the Guidance”). The Guidance outlines the procedures and criteria FDA uses to assess whether a 510(k) submission meets the minimum threshold to be accepted for substantive review. If finalized, the Draft Guidance will supersede the 1993 guidance entitled “Center for Devices and Radiological Healths Premarket Notification (510(k)) Refuse to Accept Policy” and the 1994 guidance entitled “510(k) Refuse to Accept Procedures (K94-1).”

The FDA requires that 510(k)s be submitted in an organized, tabulated document that provides sufficient information for the FDA to be able to determine whether the device is substantially equivalent (“SE”) to a predicate device. The FDA estimates that the average 510(k) submission is about 35 pages; although others may be 100 pages or more depending on the complexity of the device. The FDA has not implemented a standard 510(k) form.

The purpose of the Draft Guidance is to provide device sponsors with clarification regarding what should be included in 510(k) submissions in order to enhance the quality of submissions and improve overall FDA review time. Detailed in the Draft Guidance is an “Acceptance Checklist” that contains the criteria the FDA will use to conduct an acceptance review to ensure that 510(k) submissions are administratively complete.

According to the Draft Guidance, within 15 days of receipt of a 510(k), the FDA will conduct a review to assess whether the submission should be accepted. If one of more of the items on the Acceptance Checklist is not present, the 510(k) submission will not be accepted and will receive a Refuse to Accept (“RTA”) designation. The FDA will notify the device sponsor in writing that the submission has not been accepted and will provide a copy of the completed checklist indicating which items are the basis for the RTA designation. The 510(k) submitter may respond by providing the missing information identified in the checklist. Only when all the missing information is submitted will the 510(k) be accepted and the FDA will conduct a substantive review evaluating the quality of the content to determine if the device should be cleared.

The Draft Guidance is one of the FDAs attempts to improve its medical device application review times in order to meet the performance goals set forth in the Medical Device User Fee Modernization Act (“MDUFMA“). For more information regarding the FDAs attempts to improve review times, please see our previous report regarding the medical device pre-submission (“Pre-Sub”) program.

Some members of the medical device industry are concerned that the acceptance review of a 510(k) may be potentially time consuming and counterproductive to the FDA goals to improve review times. In a letter to the FDA, the Advanced Medical Technology Association (“AdvaMed”) on behalf of industry reasons that it may be difficult for reviewers conducting the acceptance review to determine whether certain elements are present without conducting a substantive review. Also in an effort to improve review times, AdvaMed urged the FDA to lower the bar for the acceptance criteria described in the Draft Guidance, and limit the acceptance review to allow for an effective substantive review.

The FDAs review of medical devices is complex. Fuerst Ittleman David & Joseph PL has extensive experience successfully navigating medical devices through FDA review. For more information on FDAs review of medical devices, please contact us at contact@fidjlaw.com.