FDA Readying Regulatory Plan for Digital Health Devices

Novel “post-market approach” expected this fall

Writing in a blog post, FDA Commissioner Scott Gottlieb, MD, has announced that his agency is preparing to launch a digital health innovation plan that will “include a novel, post-market approach” to digital devices. As part of that approach, the FDA also plans to release new guidance for manufacturers of digital health products.

Digital health experts were “ecstatic” over the news, particularly as the industry has been pushing for more clarity from the FDA, according to an article posted on the FierceHealthcare website. The 21st Century Cures Act broadly addressed regulating new technology, but exactly how the FDA would oversee clinical-decision support software remained ambiguous.

In his blog post, Dr. Gottlieb noted that 165,000 health-related apps were available for Apple or Android smartphones in 2016. Forecasts predict that such apps would be downloaded 1.7 billion times by 2017.

In the coming months, the “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,” Gottlieb wrote. “In addition, [the] FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low-enough risks that [the] FDA does not intend to subject them to certain pre-market regulatory requirements.”

In addition, this fall the FDA will pilot a new approach toward regulating digital-health technology, he announced, adding: “This will be the cornerstone to a more efficient, risk-based regulatory framework for overseeing these medical technologies.”

In the meantime, while the pilot program is being developed, the FDA is considering whether and how it can create a third-party certification program under which lower-risk digital-health products could be marketed without FDA pre-market review and higher risk products could be marketed with a streamlined FDA pre-market review.

“Certification could be used to assess, for example, whether a company consistently and reliably engages in high-quality software design and testing (validation) and ongoing maintenance of its software products,” Gottlieb suggested. “Employing a unique precertification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital-health technologies.”

“Through these and other steps, [the] FDA will help innovators navigate a new, modern regulatory process so that promising, safe, and effective developments in digital health can advance more quickly and responsibly, and Americans can reap the full benefits from these innovations,” he concluded.

On another front, a new Medical Device User Fee agreement is still making its way through Congress. The agreement includes a central digital-health unit within the FDA’s Center for Radiological Health.

Sources: FierceHealthcare; June 16, 2017; and FDA Voice; June 15, 2017.