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

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