FDA to pilot new regulatory pathways for digital health tools this fall

ARLINGTON, Va. – The Food and Drug Administration last week announced that this fall, as part of a comprehensive approach to the regulation of digital health tools, the agency will pilot an entirely new approach toward regulating this technology. The announcement was welcomed by industry.

"This will be the cornerstone to a more efficient, risk-based regulatory framework for overseeing these medical technologies," Scott Gottlieb, FDA commissioner, wrote in FDA Voice, the FDA's official blog. "While the pilot program is still being developed, we are considering whether and how, under current authorities, we can create a third party certification program under which lower risk digital health products could be marketed without FDA premarket review and higher risk products could be marketed with a streamlined FDA premarket review," he noted. "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. 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."

“The FDA’s anticipated, new pilot program to create a third-party certification program will transform market access, while helping innovative companies deliver  lower prices and greater choice to American consumers," stated Julie Kearney, VP regulatory affairs, Consumer Technology Association. “The FDA’s focus on the review of higher-risk products will allow innovators to navigate a modern-day regulatory process more easily, so digital health care can evolve and advance quickly and responsibly."

The FDA’s latest regulatory guidance for digital wellness apps and low-risk fitness trackers is a continuation of the agency taking steps to improve Americans accessibility to wearable health solutions. Last year, the FDA announced its commitment to creating a category for over-the-counter hearing aids. Now, Congress has included in the FDA User Fee Reauthorization bill an amendment that would allow the FDA to create the category. CTA is supportive of the provision and is running a grassroots campaign urging consumers to share their support for over-counter hearing aids with legislators.

CTA projects U.S. unit sales of all wearable tech devices will reach 48 million units in 2017 (a 14% year-over-year increase) and earn $5.5 billion in revenue (a 3% increase).