MedCon 2025 has been announced!

April 23 - 25, 2025

Columbus, OH

AFDO RAPS Healthcare Products Collaborative
MedCon Conference

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2024 MedCon Agenda

April 25, 2024 @ 10:05 am


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(PMA), Pre-submissions, 513(g) Request, and Reclassification, and potentially other topics, including the recent draft guidance documents issued, and other hot topics.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.


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


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

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.


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