September 13, 2017

CDRH Explores Streamlined Review of PMA Applications with Emphasis on Device Quality

Under Pilot Program, No Preapproval Inspections; Post-approval Inspections To Focus on Quality Controls

A pilot program announced Sept. 11 by the FDA’s Center for Devices and Radiological Health (CDRH) will seek to streamline the review of premarket approval (PMA) applications while focusing on characteristics of the medical device “consid...

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