William A. Garvin, of Buchanan’s Food & Drug Administration and Pharmaceuticals practice, weighed in on the 2016 outlook for device-related issues, including laboratory-developed tests (LDTs) – tests that are designed, manufactured and used in a single laboratory. FDA stated it will issue guidance in 2016 about LDTs and that it plans to increase its oversight of them.
“I expect there to be major fights in the LDT space in 2016,” Garvin said, adding that there is “so much uncertainty” surrounding the issue.
Garvin also spoke about international issues affecting the medical device industry in 2016, including possibly increased oversight by the FDA of foreign device manufacturing.
Read the full article – “OUTLOOK 2016: Lab Tests, Cybersecurity, Off-Label Use Among Top Device Issues” (Bloomberg BNA Medical Devices Law & Industry Report, January 12, 2016)