FDA Commissioner Announces Risk-Based Plan for Digital Health Technology


Posted June 19, 2017

Promising a “modern and efficient” regulatory process, the head of the Food and Drug Administration (FDA) announced a pilot program aimed at supporting the development of digital health technologies, saying it’s possible that lower-risk products wouldn’t even face premarket review by the agency and that higher-risk products “could be marketed with a streamlined FDA premarket review.”

As part of that pilot program, which FDA Commissioner Scott Gottleib, MD, said would launch this fall, the FDA is looking into the creation of a third-party certification program, which could play a crucial evaluation role in getting products to market.

“Certification could be used to assess, for example, whether a company consistently and reliably engaged in high-quality software design and testing (validation) and ongoing maintenance of its software products,” Gottleib wrote in a June 15 FDA blog post.  ”Employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies.”

In his post, Gottleib reiterated the FDA’s growing focus on postmarket surveillance of devices and the role that “real-world data” could and should play in supporting both innovation and the public health.

He wrote that product developers could use data gathered by the National Evaluation System for health Technology (NEST) to expedite market entry and expansion. NEST is operated by the Medical Device Innovation Consortium, a public-private partnership.

“Applying this firm-based approach, rather than the traditional product-based approach, combined with leveraging real-world evidence, would create market incentives for greater investment in and growth of the digital health technology industry,” he wrote. “Such processes could enable developers to deploy new or updated software more rapidly and would help the FDA to better focus our resources.”

Gottleib affirmed that under current policy—and as dictated in the 21st Century Cures Act—software and mobile apps that are fitness focused would not fall under FDA oversight. He promised guidance “to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect pre-existing FDA policies.”

At the same time, Gottleib signaled that FDA authority would extend to some products in the rapidly developing digital health market. Wrote Gottleib: “FDA will provide guidance to clarify our position on products that contain multiple software functions, where some fall outside the scope of FDA regulation, but others do not.”

“Greater certainty” over what is subject to regulation, Gottleib acknowledged, is key to supporting innovation and the agency making the best use of its resources, with a focus on “higher-risk priorities.”