FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

CDRH Flags Center’s Regulatory Priorities

Aug. 27, 2019

CDRH has posted its top ten regulatory science priorities, a regularly updated list designed to spur device safety, innovation and quality.

The center said that its highest priorities include incorporating “big data” and real-world evidence (RWE) in its regulatory decisions, modernization of biocompatibility and biological risk evaluation of device materials, and the advancement of tests and methods for predicting and monitoring device clinical performance, among others.

The priorities are designed to improve the “safety, effectiveness, performance and quality of medical devices and radiation-emitting products” and to “facilitate introducing innovative medical devices into the marketplace,” CDRH said.

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