The guidance includes detailed checklists for devices that applicants want to be considered for traditional, abbreviated or special 510(k) clearance. The agency said it will respond to applications within 15 calendar days from submission and will notify applicants if information is missing. When the applicant submits that information, the 15-day acceptance review cycle will begin again.
Applicants who deliberately omit information included in the checklist must give the agency a reason for why the question(s) do not apply to its device.
At any time during the 15-day period, the FDA may notify the applicant of its refusal to accept the application. Once it accepts an application, the FDA will begin its substantive review of the quality of the information provided.
The new final guidance is the latest in a series of documents on the agency’s refuse-to-accept policy. The first guidances, issued in 1993 and 1994 were not specific enough and caused FDA staff to invest “sigificant time in constructing extensive letters requesting all of the additional information needed to conduct a substantive review,” the agency said last week.
A third guidance, issued in 2012, clarified the content needed for traditional, abbreviated and special 510(k) submissions to allow the FDA to conduct a substantive review. The new guidance is intended to give FDA staff a clear, consistent approach for acceptance review for 510(k) applications and to outline the agency’s refuse-to-accept policy on 510(k)s. It will also help submitters prepare 510(k) notifications that are administratively complete for the FDA to conduct a substantive review, the agency said.