Breakout

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

Wednesday, April 23, 2025

1:20 PM – 2:35 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pre-market approval (PMA), pre-submissions, 513(g) Requests, and potentially other topics, including the recent draft guidance documents issued.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)
Josh Nipper

Director, PreMarket Operations, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH)
FDA (Invited)
Dan Schultz

Principal, Medical Devices & Combination Products
Eliquent Life Sciences