Presents
April 25, 2024 @ 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(PMA), Pre-submissions, 513(g) Request, and Reclassification, and potentially other topics, including the recent draft guidance documents issued, and other hot topics. Attendees will have the opportunity to engage with the speakers from FDA and industry 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)
Josh Nipper, Director, PreMarket Operations, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
April Veoukas, Director, Regulatory Affairs, Abbott
