FDA issues new guidance on medical device user fee refunds and exceptions

April 2, 2013 by Arezu Sarvestani

The FDA outlines cases in which a manufacturer can expect a refund of the user fees paid for the FDA's review of a medical device.

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The FDA issued new guidance this month detailing cases in which a medical device manufacturer may be eligible for a refund of the user fee paid for agency review.

The federal watchdog agency described user fee protocols for both 510k and premarket approval applications, laying out the general guidelines the FDA will follow in determining whether the applicant may be able to request a user fee refund.

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The new guidance fits with the FDA's new Medical Device User Fee & Modernization Act, which Congress authorized in June 2012 to bump up the user fees that medical device makers pay for agency review. The agency has since issued new guidances on 510(k) time-frames, PMA approval time lines, 510(k) pre-review sessions and more in efforts to streamline and clarify the medical device review pathway.

A pair of guidances issued this week aim to make clear the user fee exception and refund eligibility for various types of 510(k) and PMA applications.