A new FDA pilot program would streamline the review process for high-risk digital devices while allowing low-risk devices onto the market without FDA review.

FDA Commissioner Scott Gottlieb announced the program on the FDA’s Voice blog on June 15 as part of a broader effort within the agency to develop a framework for regulating digital health tools. As part of the pilot, Gottlieb said, the FDA is exploring creating a third-party certification pathway for lower-risk devices that would help assess the quality and reliability of a company’s software design, testing and maintenance. This certification program could allow lower-risk digital medical devices to enter the market without FDA premarket review and streamline the premarket review for higher-risk devices.

Gottlieb framed this approach as part of a broader shift in how the FDA handles the review process, moving away from product-by-product review and toward a more company-based approach, in addition to increased use of real-world evidence, such as the trial design elements that recently made the FDA the first regulatory agency in the world to approve a new transcatheter heart valve. — Zack Budryk