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Overview of FDA Device Regulation

Date: Thursday, May 11, 2017 11:00 AM - 05:00 PM

Venue: Covington and Burling LLP, Washington, DC

Scott Danzis, Denise Esposito, Pam Forrest, Christina Kuhn, and Doug Poucher will participate in this CLE program that will provide overviews of key legal/regulatory principles, as well as how to avoid common pitfalls, relating to:

  • FDA’s Quality System Regulation (21 C.F.R. Part 820)
  • FDA’s Medical Device Reporting Regulation (21 C.F.R. Part 803)
  • FDA’s Reports of Corrections and Removals Regulation (21 C.F.R. Part 806)
  • FDA’s Requirements and Policies Governing Device Promotion (including key FDA promotional policies, recent First Amendment challenges to the prohibition against off-label promotion, and FDA’s recent actions in response to the First Amendment challenges.)