Breakout

Breakout #2: One Year Into FDA’s New Regulatory Authority of Medical Device Cybersecurity + A Cybersecurity Regulatory Landscape Update

Thursday, April 24, 2025

9:55 AM – 11:25 AM East Coast USA Time

This session will explore FDA’s review and enforcement activities considering its increased statutory authority and its latest premarket cybersecurity guidance. The session will also provide an update on the current and future global regulatory landscape around medical device cybersecurity.

Moderator(s)

Eric Henry

Senior Quality & Regulatory Compliance Advisor, FDA & Life Sciences Practice
King & Spalding

Speaker(s)

Axel Wirth

Chief Security Strategist
MedCrypt
JP

Justin Post

Cybersecurity Policy Analyst, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Invited)
Chris Reed

Senior Director of Cybersecurity Policy, Global Regulatory Affairs
Medtronic