Uncovering risks and opportunities: Insights into the U.S. Regulatory Environment for Medical Devices 


Bringing innovative medical devices to market in the U.S. requires navigating the choppy waters of FDA regulations.  There are governing laws and regulations for every stage of the product life cycle—from product development and clinical trials through premarket submission reviews to compliance with postmarket requirements.  Positioning a product for success demands a firm grasp of the processes, issues, trends in order to prepare for, as well as uncover, the risks and opportunities.

Join Jonathan S. Kahan, John J. Smith and Moshe Kasser of Hogan Lovells for a complimentary lunch and an interactive discussion of:

  • Current trends in FDA’s review of traditional and Special 510(k) notices
  • Developments in  the agency’s “refuse to accept” (RTA) process
  • FDA’s Expedited Access Pathway (EAP) program and its application
  • Strategies for the conduct of clinical trials, including the use of foreign data to support marketing submissions
  • Effectively using pre-submissions and Submission Issue meeting processes
  • Developments in the regulation of combination products, including combinations of devices with drugs, biologics and human tissue


This is a great opportunity to get answers to burning questions from a team who has helped medical device manufacturers of all sizes successfully bring innovative products to market.