Engaging the FDA: An Insider's Perspective

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On June 14th, OBIO invites you to a unique opportunity to hear from Dr. Yuan Fang, Vice President of Regulatory Affairs, Quality and Manufacturing at Focal Healthcare Inc. 

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.