Primer on US FDA’s New 510(k) Refuse to Accept Policy

The US Food and Drug Administration’s revised Refuse to Accept (RTA) policy (links to PDF document) for 510(k) applications that lack all required documentation is now in effect. Medical device manufacturers planning to undergo the premarket notification process should familiarize themselves with steps necessary to get their applications back on track in the event that they receive an RTA notice from the FDA.

The agency’s new RTA process is currently in effect, and involves an early review of 510(k) applications to determine whether they are “administratively complete,” or contain all materials necessary for the regulator to conduct a substantive review. The RTA screening precedes the full-blown premarket notification review that determines 510(k) clearance of a device.

The FDA’s RTA review process includes the following steps:

  1. Upon submission of a 510(k) application, the FDA has 15 days to decide whether to accept that submission based on administrative completeness.
  2. The FDA’s RTA review covers all traditional special and abbreviated 510(k) applications using the Acceptance Checklist found on page 15 of the agency’s RTA guidance from December 2012. If any of the items on the RTA Acceptance Checklist are not found in the 510(k) application, the FDA will notify the applicant in writing of which items are missing.
  3. The applicant may respond to the FDA RTA notice by providing the missing information.
  • Missing information should be included in the file under the applicant’s original 510(k) number.
  • A new submission and user fee are not required to provide the missing information.
  • The applicant may submit only the information requested in the FDA RTA notice.
  • The applicant has 180 days to respond to the FDA RTA notice; if there is no response within that timeframe, the FDA will consider the 510(k) to be withdrawn.

Once the applicant has submitted the missing information to the FDA, another initial review to determine administrative completeness will be done. If the 510(k) application is accepted for substantive review, the FDA will notify the applicant.

Medical device manufacturers may face a delayed path to market in the US if they run afoul of the FDA’s new RTA policy. It is crucial going forward that FDA 510(k) applicants take all steps necessary at the beginning of their registration process to ensure that their submissions are both accurate and complete.