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'Refuse-To-Accept' Policy Outlined For De Novos In New US FDA Draft Guidance

Following a user fee deal that will subject de novo applications to performance goals and user-fee payments, US FDA has proposed a guidance that attempts to explain its process for considering when to accept, and when not to accept, a de novo submission for review.

US FDA is proposing checklists sponsors should use when filing a de novo application in a draft guidance that seeks to outline the minimum standards for a de novo submission to be accepted for review and timelines for FDA to assess acceptance criteria.

The draft guidance, "Acceptance Review for De Novo Classification Requests," is linked to new commitments the agency made in the MDUFA IV user-fee program, which took effect Oct. 1, for its review of de novo submissions, which can be used as a marketing pathway for low-to-moderate risk devices that lack a predicate. The draft guidance was issued in conjunction with FDA finalizing another

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