MedCon 2024, co-sponsored by the FDA

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April 25, 2024

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10:05 am

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12:00 pm

Navigating Recent Changes: An Update on Premarket Programs

Pre Market Track

This session aims to provide the latest updates concerning FDA’s three critical pre-market pathways in medical device regulation: 510(k) Notice, De Novo Classification, Pre-Market Approval (PMA), Pre-submissions, 513(g) Request, and potentially other topics, including the recent draft guidance documents issued. Attendees will have the opportunity to engage with the speakers during the Q&A segment, allowing for a dynamic exchange of ideas and clarification on pressing issues. Don’t miss this opportunity to stay updated.

Moderator

Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health, Inc
Vice President Regulatory Affairs, MDMA
Fatemeh Razjouyan, Director of Regulatory Policy, International and Harmonization | Global Regulatory Policy, Medtronic

Speakers

Mark Leahey, President & CEO, Medical Device Manufacturers Association (MDMA)
Toby Lowe, Associate Director for Regulatory Programs, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health (CDRH), FDA (Invited)
Josh Nipper, Director, PreMarket Operations, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
Mary Wen, Regulatory Advisor, Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH), FDA