Premarket Approval (PMA) Agreement with FDA for the Medical Device Companies

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)). To do this, companies must submit valid scientific evidence (21 CFR 860.7(c)), typically derived from a clinical study. The application also needs to include documents demonstrating compliance with the Quality Systems Regulations (QSRs) (21 CFR Part 820). The PMA must also include draft labeling, information regarding product composition, preclinical data, and a summary of relevant literature (21 CFR 814.20(b)).
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[@SamHarmony2]

Thank you for the content. Very helpful! Is it possible to receive a copy of this powerpoint presentation?