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

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.

Kristin M. Zielinski Duggan, Partner, Hogan Lovells US LLP

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