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RAPS' “how to” guide to developing a comprehensive global regulatory strategy for all types of medical devices. Updated September 2020.
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Posted 01 July 2011 | By Mike Ronnigen, RAC,
Submitting a Premarket Approval Application (PMA) for a Class III medical device to the US Food and Drug Administration (FDA) initiates a cascade of activities that requires the company to be operating at peak performance. Once the PMA is submitted, it is logged and issued to the Division of Bioresearch Monitoring (DBM) for assignment of initial review to determine whether it is fileable.
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