RAPS: US Regulation of Advertising, Promotion, and Labeling for Medical Devices

Virtual Program (ET)

Bradley Merrill Thompson, Member of the Firm, will speak on two panels at the "US Regulation of Advertising, Promotion, and Labeling for Medical Devices" virtual program, which runs from June 17 to 18, hosted by the Regulatory Affairs Professionals Society (RAPS).

Industry leaders, regulatory, and legal professionals will share what they know on medical device advertising, promotion and labeling in the US. Through presentations, discussions and case studies, this virtual program will examine current guidelines and expectations for medical devices and how they impact the way to communicate with prospective and end users.

Mr. Thompson will speak on the following panels:

Intended Use & Off-Label Promotion

  • Understanding the law & past FDA enforcement against off-label use promotion
  • Mechanisms for discussing off-label uses
  • Off-label use and clinical trial strategy
  • Social media promotion

Case Study on Using Real-World Evidence to Support a Marketing Claim and Q&A

  • Evaluate and use real-world data (RWD) and real-world evidence (RWE) in promotion
  • Discover regulatory applications through case studies

For more information and to register, please visit RAPS.org.