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Engaging with the FDA: An Insider's Perspective

Get behind-the-scenes on the recent changes at the FDA and learn more about how regulatory process changes affect your company:

  • Understand FDA’s vision and approach to driving innovation under Commissioner Dr. Scott Gottlieb, and how recent changes in the agency will affect premarket submissions and inspections.
  • Learn how and when you should be engaging with the FDA.
  • Find out what the FDA is looking for in 510(k), DeNovo, and PMA submissions & recent approvals of devices with AI and machine learning features.

Featuring: Dr. Yuan Fang (VP of Regulatory Affairs, Quality and Manufacturing, Focal Healthcare Inc.)

Dr. Fang spent over 8 years at the FDA Center for Devices and Radiological Health (CDRH) and was the recipient of the prestigious FDA Outstanding Service Award for Total Product Life Cycle (TPLC) management.

Register here.