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:
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.