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.

Quynh Hoang, Senior Regulatory Consultant, King & Spalding LLP

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