FDA released a final version of its guidance document, Refusal to Accept Policy for 510(k)s, on December 31, 2012, closing out the year with additional changes to the 510(k) process.

FDA has had a refusal to accept policy for 510(k)s for some time, which was stated in a 1993 guidance document of the same name and a 1994 blue book memorandum.  As part of its goals commitment for the most recent iteration of the user fee legislation, the Food and Drug Administration Safety and Innovation Act, FDA committed to implementing “revised submission acceptance criteria.”  In addition to publishing new guidance documents, FDA committed to communicating with an applicant regarding whether the submission is “accepted for review” within 15 calendar days of FDA’s receipt of a 510(k) submission.

The new guidance document implements this commitment by setting forth FDA’s new policy for reviewing 510(k) submissions for completeness.  The guidance states that FDA will conduct an “acceptance review” of all 510(k)s — traditional, special, or abbreviated — based on an “Acceptance Checklist” appended to the guidance document.  For the submission to be accepted, all elements must be present or not applicable (with a rationale given).  FDA will conduct the acceptance review during a 15 calendar-day period that starts upon FDA’s receipt of the submission, provided that sponsor has paid the user fee and also provided a validated “eCopy” of the submission.   On the same day, FDA also released a final guidance document on its eCopy program.

If one or more items required for acceptance are missing, FDA staff will obtain “management concurrence” and notify the submitter, who will be provided with an opportunity to submit the required additional information.  If a response to a refusal-to-accept notification is not provided in 180 days, FDA will consider the 510(k) to be withdrawn.  When a submission is accepted, FDA will notify the sponsor in writing.  In cases where FDA fails to complete the acceptance review in 15 days, the sponsor will be notified in writing that the acceptance review was not completed and the submission is under substantive review.  In such cases, FDA may request additional information during the substantive review.

For purposes 510(k) review goals, the “review clock” will begin on the date of FDA’s receipt of “the most recent submission or additional information that resulted in an acceptance designation for the 510(k).”  Once the submission is under substantive review, the calendar days used to conduct the acceptance review (i.e., up to 15 days) are included within the 60 calendar days to reach the “substantive interaction” goal FDA committed to in its user fee goals.

The final guidance differs in some respects from the draft version of the guidance released in August of 2012.  As discussed in the accompanying federal register notice, some comments submitted on the draft guidance took the position that FDA’s acceptance criteria were subjective and would require reviewers to engage in a preliminary substantive review.  In response to these concerns, FDA revised aspects of the guidance to make clear that the 15-day period is not intended to be used for a substantive review of the 510(k); the acceptance review is intended to determine only whether the submission is administratively complete.  The final guidance also provides more detail on how a submitter should provide information about prior submissions and FDA feedback.  The guidance document suggests that submitters include a separate section giving prior submission numbers, copies of FDA feedback, and a statement of how the feedback was addressed.