The US Food and Drug Administration (FDA) has updated its final guidance on its “refuse-to-accept” (RTA) policy for 510(k) submissions. The revised guidance continues to include detailed checklists for Traditional, Abbreviated and Special 510(k)s, in which some detail changes have been made.
The agency will respond to submissions within 15 calendar days from receipt with a notification that the submission has been accepted for ‘substantive review’, or that the submission is incomplete, with details of the data gaps being provided in the relevant RTA checklist. Once the applicant submits the missing information, the 15-day acceptance review cycle will begin again.
Copies of the new guidance can be accessed from here.