FDA FIRST-ROUND IDE APPROVAL RATE CLIMBS TO 70%, ALPERT REPORTS AT RAPS MEETING; TIER 1 IN VITRO DIAGNOSTIC 510(k) REVIEWS AVERAGE 22 DAYS UNDER DCLD PILOT
This article was originally published in The Gray Sheet
Executive Summary
FDA is approving 70% of investigational device exemption applications within the first 30-day review cycle, Susan Alpert, Director of FDA's Office of Device Evaluation, told attendees at the Regulatory Affairs Professionals Society annual meeting Sept. 10 in Washington, D.C. The agency's ability to improve the percentage of IDE applications approved in the first review cycle marks the "greatest success in terms of percentage turnaround" at ODE, Alpert said.
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