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

Get Access

  • +$100 for nonmembers

Internet Explorer and Microsoft Edge are not supported by the checkout process.

Please use Chrome, Firefox, or Safari.  If you are unable to use these browsers, please contact us at 202-371-1420 or [email protected] and we will assist you.

Virtual Learning FAQ

On-demand webinar content is sent via email as soon as we are able to process and verify your order. This usually occurs within 1 business day.


On-demand content can be played back on most devices.


CLE credit is not currently available for pre-recorded sessions.

Related Content