Join Us for a Seminar on the FDA's Breakthrough Devices Program!

Discover how the FDA’s Breakthrough Devices Program is transforming the future of medical devices and healthcare innovation. This voluntary program is designed to fast-track the development, assessment, and review of certain medical devices and device-led combination products that offer more effective treatments or diagnoses for life-threatening or irreversibly debilitating conditions.

What You’ll Learn:
● How the Breakthrough Devices Program accelerates access to life-saving medical devices through premarket approval, 510(k) clearance, and De Novo marketing authorization.
● The FDA’s rigorous standards for device safety and effectiveness. ● The program’s role in advancing medical innovation and protecting public health.
● How the Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review. ● Is my device eligible? ● When do I request Breakthrough Designation?
● How to request Breakthrough Designation?
● What is FDA's review process and timeline for Breakthrough Designation requests?

Don’t miss this opportunity to explore how the FDA is driving medical device innovation while ensuring safety and effectiveness. Whether you’re a healthcare provider, medical device manufacturer, or innovator, this seminar will provide valuable insights into the regulatory pathway for breakthrough devices.

Speaker

William (Bill) Sutton is President of William Sutton Consulting, LLC and currently serves as the VP of North America at Mid-Link Biomedical Technology Group in Tianjin, China. Mr. Sutton dedicated 37 years of service to the FDA, excelling as a medical device specialist with a primary focus on industry education. During his tenure at the FDA, he served as an Administrative Reviewer at the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), and as a Supervisory Consumer Safety Officer and Deputy Division Director at the Industry and International Assistance Program in the Division of Industry and Consumer Education (DICE). His most pivotal position at the FDA was a U.S. diplomat, Assistant Country Director and International Program and Policy Analyst for medical devices at the FDA China Office in Beijing, China from June 2016 to September 2020. He holds a Bachelor of Science in Management Studies from the University of Maryland.

When

Oct 26 2024 (Saturday)

5:00-7:00 PM (PDT) onsite

5:30-7:00 PM (PDT) Zoom

Where

Zoom meeting and

Irvine water district conference room, 15600 Sand Canyon Ave, Irvine, CA 92618

Free Registration

registration link for onsite  (Free parking and light refreshment)

registration link for Zoom

Questions

Website: http://www.sabpa-ocla.org

Email: Sabpa.ocla@gmail.com