April 25, 2024 @ 3:40 pm
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4:40 pm
FDA and Industry Panel Q&A on Hot Topics
Plenary Session
Moderator
Aaron Dunbar, Vice President Quality Systems & Post Market, Boston Scientific
Kim Trautman, Medical Device, IVD and Combo Product Expert
Speakers
Sean Boyd, Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
Gina Brackett, Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Phil Pontikos, Investigator, Medical Device National Expert, Division of Medical Products and Tobacco Program Operations Branch, Office of Regulatory Affairs (ORA), FDA
Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products, Greenleaf Health, Inc | Vice President Regulatory Affairs, MDMA
Monica Wilkins, VP Regulatory and Quality, Abbott
Jessica Zeller, Vice President, Quality, Regulatory, Environmental, and Public Affairs Counsel, Edwards Lifesciences