FDA to create centralized digital health unit

The Food and Drug Administration is creating a digital health unit within its Center for Devices and Radiological Health in an effort to develop internal technical expertise, and streamline the agency's software review process and regulation of medical devices. "Because it's such an emerging area, having a centralized unit in the Center Director's Office is important for coordination on digital health topics and having consistency in applying policies," says Bakul Patel, associate director of digital health in the FDA's CDRH. Also See: FDA's medical device arm ramps up HIT strategies The digital health unit will be established in the CDRH's Office of the Center Director as part of the next iteration of the Medical Device User Fee Amendments, under which the FDA is authorized to collect user fees from medical device manufacturers. In exchange for those fees, FDA commits to meeting certain performance goals, such as reviewing submissions within specified timeframes. The medical device users fees, which must be reauthorized every five years, expire in September.