FDA Clarifies “Refuse to Accept” Policy for 510(k) Submissions

The U.S. Food and Drug Administration (FDA) has issued an updated guidance to explain its criteria for assessing whether a medical device premarket notification (510(k)) submission meets the agency’s minimum requirements for substantive review.

Under the Medical Device User Fee and Modernization Act (MDUFA) and its successive amendments, the FDA must meet performance goals related to the agency’s review of medical device submissions, based on the timeliness of those reviews. The FDA’s Refuse to Accept (RTA) policy provides for an early review of all submissions in accordance with specific acceptance criteria and enables the agency to inform a submitting party whether it a submission is “administratively complete” within 15 days of its filing.

The FDA says that the guidance, titled “Refuse to Accept Policy for 510(k)s,” is intended to ensure consistency in acceptance decisions made by the agency and to help submitters better understand the types of information needed by the FDA to conduct its review.

The guidance includes several appendices that provide detailed “Acceptance Checklists” to be used by device manufacturers to verify that their submission for Traditional, Abbreviated, or Special 510(k) notification meets the FDA’s requirements for review by the agency.

According to the FDA, the guidance will promote a more efficient approach to the review of medical devices by reducing review backlogs and clearing a path for the prompt review of safe and effective medical devices. But, like all guidances, the FDA’s guidance on its RTA policy represents only the agency’s current thinking on the topic and is not binding on either the FDA or the public.

Read the FDA’s final guidance on its RTA policy for 510(k) submissions.

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