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

Learn the required elements and FDA review considerations for Premarket Approval applications. Understand the required contents and FDA review considerations for Humanitarian Device Exemption (HDE) applications. Recognize post-approval and post-marketing considerations for approved PMAs and HDEs.

Claire W. Dennis, Associate, Arnold & Porter LLP

This session was recorded as part of FDLI’s Virtual Introduction to Medical Device Law and Regulation Course in October 2024.

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Kiana Walker2024-11-21T13:41:35-05:00