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FDA Plans To Audit Its New 510(k) Refuse-To-Accept Program

This article was originally published in The Gray Sheet

Executive Summary

Results of the planned June audit will be of significant interest to a number of device companies that claim FDA reviewers have erroneously crossed into substantive review territory in applying the new "quick review" procedure.

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More Leeway For Reviewers In Updated 510(k) 'Refuse-To-Accept' Policy

An updated 510(k) “refuse to accept” guidance document gives FDA staff more opportunity to work with sponsors to smooth out product submissions without repeatedly halting and restarting the review clock with RTA determinations.

Industry, FDA Start To Settle Into 510(k) Refuse-To-Accept Program

After a rocky start, the rate of 510(k)s being turned away by FDA before full review under the refuse-to-accept program has steadily declined, and industry expects continued improvement.

Small Uptick In 510(k) Clearances In Fiscal 2014

FDA cleared 3,103 510(k)s in the fiscal year that ended Sept. 30, averaging about 259 per month, based on a review a FDA’s monthly 510(k) listings. That is up from 2,995 clearances – a 250 per-month average – in FY 2013.

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