Speaking Engagements April 8, 2025  |  3:05 PM - 4:20 PM ET

2025 Introduction to Medical Device Law and Regulation – Food and Drug Law Institute (FDLI)

Food and Drug Law Institute (FDLI)

Tuesday, April 8 • 3:05 p.m. – 4:20 p.m. ET

Partner Judy O’Grady will be speaking at the 2025 Introduction to Medical Device Law and Regulation virtual course hosted by the Food and Drug Law Institute (FDLI) on April 8, from 3:05 p.m. – 4:20 p.m. ET.

Judy will be discussing a number of topics including Premarket Approval Application (PMA); Humanitarian Device Exemption (HDE); the Breakthrough Devices Program; and Safer Technologies Program.

Explore the essentials of device law and regulation and gain a comprehensive understanding of the administrative agencies that impact this industry. Learn about registration and listing procedures, elements of conducting clinical investigations, Premarket Approval Application, advertising and promotion, compliance, enforcement, and related issues. Case studies, hypotheticals, and ample time for Q&A are provided.