• FDA Announces Public Meeting to Discuss Plans to Regulate Laboratory Developed Tests as Medical Devices
  • July 1, 2010 | Authors: Scott D. Danzis; Ellen J. Flannery; Richard F. Kingham
  • Law Firm: Covington & Burling LLP - Washington Office
  • On June 16, 2010, FDA announced that it will hold a public meeting on July 19 and 20, 2010 to discuss the agency’s intention to regulate laboratory developed tests (“LDTs”) as medical devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”). The purpose of the meeting is to allow for public input on this new initiative. In its meeting announcement, FDA stated that it intends to apply a risk-based approach to the regulation of LDTs, and following the meeting FDA “will move forward expeditiously to develop a draft oversight framework.”