MedTech (R)evolution

Super Session

Regulatory, Quality and Good Manufacturing Practices

The New World of 510(k)

Super Session Speaker(s)

• 

  Jeff Shuren, MD, JD

  Director, Center for Devices and Radiological Health
  Food and Drug Administration

Panel Session Speaker(s)

• SA

  Susan Alpert

  Principal
  SFA Consulting
• MM

  Maureen Mulvihill, PhD

  President and CEO
  Actuated Medical, Inc.
• 

  April Veoukas, JD

  Director, Regulatory Affairs
  Abbott

Panel Session Moderator(s)

• PD

  Phil Desjardins

  Vice President, Global Regulatory Policy & Intelligence
  Johnson & Johnson

For over 40 years, FDA's 510(k) process has provided a safe and efficient path to market for the vast majority of medical devices and diagnostics. Over that time, the process has continually evolved to adapt to the rapid pace of MedTech innovation and new health care issues. The 510(k) process may be poised for another evolutionary leap as FDA has proposed a number of significant changes to this bedrock regulatory paradigm. Learn from senior FDA management what the future holds for 510(k) and what industry thinks of this new phase in regulation.