MedCon 2024, co-sponsored by the FDA

Back to MedCon Agenda 2024

April 25, 2024

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3:40 pm

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4:40 pm

FDA and Industry Panel Q&A on Hot Topics

Plenary Session

A panel of MedCon committee members from FDA and Industry will address questions submitted by attendees to address the hot topics you’ve been wanting to hear about. In addition to technical topics, discussion points will include:
• Recognizing the communication pathways for manufacturers to speak to ORA and CDRH.
• Understanding the FDA to know who the needed experts are and how to contact them.
• Utilizing the FDA CDRH Division of Industry and Consumer Education (DICE) and its resources.

Moderator

Kim Trautman, Managing Director and VP, MedIcept, Inc.

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
Aaron Dunbar, Vice President Quality Systems & Post Market, Boston Scientific
Phil Pontikos, Investigator, Medical Device National Expert, Office of Regulatory Affairs/OO/OMPTO, Division of Medical Products and Tobacco Program Operations Branch, FDA (Invited)
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, VP Quality, Regulatory & Public Affairs Counsel, Edwards Lifesciences