The U.S. Food and Drug Administration (“FDA”) has announced plans to create a centralized digital health unit within the Center for Devices and Radiological Health (“CDRH”), further supporting CDRH’s 2016-2017 vision to establish a more robust national evaluation system for medical devices.  FDA will form the new digital health unit within CDRH’s Office of the Center Director as part of the fourth iteration of the Medical Device User Fee Act (“MDUFA IV”).  The MDUFA program generally authorizes FDA to collect user fees from medical device manufacturers in support of streamlining the regulatory approval process.  Negotiations between FDA and the medical device industry are currently underway, and once final, MDUFA IV will be in place for five years beginning October 1, 2017 through September 30, 2022.  As part of the negotiation process, FDA proposed to hire a number of full-time equivalent technical experts to staff the new digital health unit.

Section 3022 of the 21st Century Cures Act legislation also requires FDA to develop a framework for evaluating real world evidence to support drug approval for new indications and post-approval study requirements. FDA envisions the new digital health unit will similarly monitor and implement the use of real world evidence in the context of premarket decision-making for medical devices, therefore bridging at least part of the gap between the drug and medical device regulatory schemes.  FDA already issued draft guidance in July 2016 outlining acceptable uses of real world evidence as applicable to the medical device regulatory approval process.

In addition to FDA’s vision of streamlining the medical device regulatory approval process, once formally established, the digital health unit will require substantial cross-coordination with industry and other government agencies, as digital health touches on areas such as artificial intelligence, data privacy and cybersecurity, telemedicine, and the cloud.