Workshop A – FDA Device Law 101: Introduction to the Fundamentals

Jul 26, 2017 1:00pm – 4:00pm

Sonali P. Gunawardhana
Of Counsel
Wiley Rein LLP (Washington, DC)

Sally L. Maher
VP Regulatory Affairs
Edwards Life Sciences (Irvine, CA)

This workshop, tailored for professionals who have limited or no experience working with FDA on medical device regulatory matters, provides a basic overview of FDA device regulations. Topics addressed during this workshop will set the stage for the main conference by helping attendees thoroughly comprehend the structure of FDA and obtain a basic understanding of the pre-approval, approval, and postapproval process. Get the background you need to flow seamlessly into the more in-depth discussions that will take place throughout the conference. Topics include:
  • Introduction to FDA
  • History of FDA and device regulations
  • The Basics of Device Classification and FDA’s Review Process
  • Clinical Trials Process (IDEs)
  • Premarket Approvals (PMAs)
  • 510(k) Clearance Process
  • Labeling: Key Regulatory Requirements, Information, and Concepts
  • Post-Market Issues and Enforcement
  • Recalls and Withdrawals
  • Recent Developments at FDA