The Premarket Approval (PMA) pathway is complex. The PMA application needs to provide a reasonable assurance that the device is safe and effective for its intended use (21 USC 360e(d)(1)(A)).
Premarket Approval (PMA) Agreement with FDA for the Medical Device Companies - Webinar by GlobalCompliancePanel
12 December 2013, Fremont, United States
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Online Training, 161 Mission Falls Lane, Suite 216,, California, Fremont, 94539, United States
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