US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would 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 review.
The pilot, part of a new approach to regulating digital health tools, would help to certify, according to Gottlieb, 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."
FDA also will provide guidance clarifying its stance on products that contain multiple software functions and which currently fall outside FDA regulations.
"In addition, FDA will provide new guidance on other technologies that, although not addressed in the 21st Century Cures Act, present low enough risks that FDA does not intend to subject them to certain pre-market regulatory requirements," Gottlieb wrote in FDA’s Voice Blog.
The push into digital health comes as Bakul Patel, associate center director for digital health at FDA, recently told conference attendees that guidance related to software as a medical device, and a new dedicated unit to digital health are coming to FDA’s Center for Devices and Radiological Health (CDRH).
Gottlieb also noted that the postmarket collection of real-world data might be able to be used to support new and evolving product functions.
"For example, product developers could leverage real-world data gathered through the National Evaluation System for health Technology (NEST) to expedite market entry and subsequent expansion of indications more efficiently ... The Medical Device Innovation Consortium (MDIC), a 501(c)(3) public-private partnership, is serving as an independent coordinating center that operates NEST. In the coming weeks, MDIC will announce the establishment of a Governing Committee for the NEST Coordinating Center comprised of stakeholder representatives of the ecosystem, such as patients, health care professionals, health care organizations, payers, industry, and government," Gottlieb wrote.
NEST’s fully operational system is expected to come by the end of 2019.