Medical Device Premarket Approval Applications (PMA); Humanitarian Device Exemption (HDE) and Breakthrough Devices: An Introduction

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Recorded November 16, 2022 | On-Demand Webinar

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.

This session was recorded as part of FDLI’s virtual Introduction to Medical Device Law and Regulation course in November 2022.

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