Medcon 2023: Shuren Mulls New Pathway For Digital Devices

The head of the US FDA’s Center for Devices and Radiological Health said that an optional new pathway could help the agency regulate the flood of novel devices intended for at-home use. His presentation also touched on MDUFA V implementation, post-pandemic strategy, and CDRH staffing needs.

The US Food and Drug Administration may need to create a better pathway for the regulation of software-based devices, device center head Jeff Shuren said on 25 April at Medcon 2023 in Columbus, OH.

Shuren spoke to the meeting, which was held in person for the first time since 2019, via videoconferencing. [(A#MT145274)]