Breakout

Breakout #3: What’s New in CDRH Premarket Programs: Insights and Updates From Industry Experts

Wednesday, April 23, 2025

1:00 PM – 2:15 PM East Coast USA Time

This session aims to provide the latest updates concerning FDA’s premarket pathways in medical device regulation: 510(k), De Novo classification, pre-market approval (PMA), pre-submissions, 513(g) Requests, and potentially other topics, including the recent draft guidance documents issued. This session will also delve into how MDUFA V commitments are impacting FDA and stakeholders, which is particularly important as we approach MDUFA VI. Attendees will have the opportunity to engage with the speakers during the Q&A segment, allowing for a dynamic exchange of ideas and clarifications on pressing issues. Don’t miss this opportunity to stay updated.

Moderator(s)

Heather Rosecrans

Executive Vice President, Medical Devices & Combination Products
Eliquent Life Sciences | Vice President Regulatory Affairs, MDMA

Speaker(s)

Mark Leahey

President & CEO
Medical Device Manufacturers Association (MDMA)
Dan Schultz

Principal, Medical Devices & Combination Products
Eliquent Life Sciences