Regulatory News

FDA to Create Digital Health Unit

With ongoing work on guidance related to software as a medical device, and a new dedicated unit to digital health coming to the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), the agency is slowly but surely dipping its toe into the rapidly advancing field.

Bakul Patel, ‎associate center director for digital health at FDA, told attendees at MedCon in Cincinnati on Thursday that current work is directed at funneling through about 1,400 comments on draft guidance on software as a medical device released last October, which is also a priority for the International Medical Device Regulators Forum (IMDRF).

Patel noted that FDA is currently working on "what clinical validation looks like for software," adding that the 46-page document will likely be simplified to 20 pages when finalized.

A lot of the debate from the comments centered around how to define scientific and clinical validation, Patel said, noting the incredibly rapid lifecycle of software programs and the difficulty of regulating them.

And in terms of FDA’s new digital health unit, which will be established within CDRH’s Office of the Center Director thanks to the next iteration of the Medical Device User Fee Amendments, Patel noted that the unit will need cross-coordination and will explore opportunities to establish premarket approval and/or clearance pathways tailored for digital health that take into account real world evidence.

"How do we credit people who are doing the right things?" Patel said.

He also noted that some of the language in the recently passed 21st Century Cures Act "put a wrinkle in our plans" to tackle digital health and forced the agency to take a step back. However, he acknowledged that FDA will release some discussion of the Cures legislation.

"As we go forward, it shouldn’t stop you folks from going forward," he told medical device industry leaders at the conference.

Other topics that FDA’s digital health unit will devote time and resources to include artificial intelligence, advanced analytics, the cloud, wireless medical devices, telemedicine, interoperability, health IT and cybersecurity.