Hot Topics and Recent Developments in Medical Device Regulation and Enforcement
2:15 pm - 3:25 pm
One Boston Scientific Place, Natick, MA
American Bar Association
Speaker: Craig R. May
Medical devices are one of the most heavily regulated products on the market in the United States. FDA's regulation of devices, and the government's action in enforcing the regulations, change over time. WTO partner Craig May
will moderate this panel discussion on important current regulatory and enforcement issues and how those might impact litigation for device companies. Topics to be covered include: evolving FDA requirements on post market surveillance and Section 522 studies and what recent FDA actions in this area mean for companies; off-label promotion and advertising of medical devices, an area where the government has recently shifted more investigation and enforcement focus to medical devices, with major potential implications for litigation; MDR reporting requirements and the recent trend toward over-reporting in response to FDA policies and enforcement, with resulting potential policy and litigation implications; and the coming FDA regulation of standalone software and mobile apps, which will become more and more common in healthcare delivery. The panel will use examples of publicly reported cases and investigations and will invite feedback from the audience on its own experience with these issues.