Medical Innovation Exchange

CDRH

CDRH Launches Pilot Program To Reduce Device Approval Times

CDRH Launches Pilot Program To Reduce Device Approval Times     The FDA Center for Devices and Radiological Health (CDRH) is launching the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. “TAP is a voluntary program intended to de-risk the medical device valley of death by providing industry with earlier and more frequent interactions with …

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CDRH Seeks Medical Device Sites for Review Staff Education

CDRH Seeks Medical Device Sites for Review Staff Education     To help reviewers keep pace with rapid advances in medical devices and technologies, the FDA’s Center for Devices and Radiological Health (CDRH) developed the Experiential Learning Program (ELP). ELP provides CDRH review staff with an opportunity to visit sites and gain a better understanding of …

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