Medical Device Premarket Approval Applications (PMA) and the Humanitarian Device Exemption (HDE): An Introduction

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Medical Device Premarket Approval Applications (PMA) and the Humanitarian Device Exemption (HDE): An Introduction

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Recorded March 3, 2021 | On-Demand Webinar

Review the legal basis and content of a Premarket Approval Application. Differentiate between a 510(k) and a PMA. Outline the contents of a PMA. Explore Humanitarian Device Exemption requirements.

This session was recorded as part of FDLI’s virtual Introduction to Medical Device Law and Regulation course in March 2021.

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