Fewer 510(k) Outliers Expected With User Fees; FDA Offers Guide To MDUFMA
This article was originally published in The Gray Sheet
Executive Summary
Device user fee implementation is not expected to have a significant near-term impact on average premarket notification review times, according to CDRH staffers, although the fees may help rein in times for "outliers," 510(k)s that take an unusually long time to review
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RAPS In Brief
PMA ABCs: Action definitions and procedures guidance will explain terms related to all PMA decisions listed under the performance goals of MDUFMA, ranging from "approval" and "approvable pending GMP" to "denial" and "abandonment," CDRH Premarket Approval Section Director Thinh Nguyen reports at the Regulatory Affairs Professionals Society medical device conference in San Francisco March 4. One of six PMA-related guidances under development, the document will provide criteria for decision letters and explain how certain actions affect FDA's review clock and performance goals...