FDA released yesterday a draft guidance entitled, “Refuse to Accept Policy for 510(k)s,” that seeks to clarify and ultimately replace existing policy documents explaining when a medical device premarket notification (510(k)) submission is administratively complete and ready for substantive review. The draft guidance comes after last month’s third renewal of the Medical Device User Fee and Modernization Act (MDUFA III) as part of the FDA Safety & Innovation Act (FDASIA), which both reauthorizes fees for medical device applications and sets performance goals for the timeliness of FDA reviews. According the FDA, the draft guidance will streamline review by “encouraging quality submissions from sponsors of 510(k) notifications and allowing FDA to appropriately concentrate resources on complete submissions.”
The draft guidance would modify FDA’s Refuse to Accept (RTA) policy to include a preliminary administrative review within 15 calendar days of receipt of a 510(k) submission. The administrative review process seeks to reduce FDA’s acceptance of incomplete submissions by requiring personnel to check each submission against the applicable checklist based on 510(k) type (i.e., traditional, special or abbreviated). If any items on the checklist are not present and no explanation is provided for the omission, the submission should not be accepted and designated as RTA. Upon notification of RTA status, the submitter should submit the missing information, or an explanation for the omission, but need not resend the entire submission or provide a new user fee.
If FDA fails to conduct the administrative review within 15 calendar days of receipt, the submission will be considered accepted and FDA should begin substantive review. FDA may subsequently ask for any additional information necessary to conduct the substantive review, even if that information was overlooked in the administrative review. The draft guidance emphasizes that the administrative review is entirely independent from the substantive review and only examines the presence of required information, not the sufficiency of that information. Once administrative review is complete, substantive review under section 513(i) of the Federal Food, Drug & Cosmetic Act depends on whether the device has the same intended use as the predicate device, and either (1) the same technological characteristics as the predicate device, or (2) different technological characteristics, but the submission contains information that demonstrates the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.
While interested parties may submit comments on any guidance at any time, FDA encourages comments on the draft guidance to be submitted by September 27 in order to ensure they are considered before FDA commences work on the final version of the guidance.