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.