RAPS In Brief
This article was originally published in The Gray Sheet
Executive Summary
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...