FDA Commissioner Scott Gottlieb, M.D. recently announced the agency’s Digital Health Innovation Plan (the “Plan”)—a new agency-wide initiative to foster “innovation at the intersection of medicine and digital health technology.”  Dr. Gottlieb provided an overview of the components of the Plan, which include: (1) guidance documents implementing the digital health provisions of the 21st Century Cures Act; (2) guidance documents on low-risk digital health products; (3) a third-party certification pilot program; and (4) use of real-world evidence to support the development of digital health products.  While the Commissioner previewed the new Plan, he explained that details of each component would be forthcoming.  The Plan appears to align with the approach previously advanced by the Center for Devices and Radiological Health (CDRH) regarding digital health.

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