Lexology January 21, 2026
On January 2, 2026, the US Food and Drug Administration (FDA) began accepting statements of interest for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, a program designed to accelerate access to digital health devices while maintaining patient safety. The initiative reflects FDA’s evolving approach to digital health oversight, favoring flexibility and real-world evidence over traditional premarket review. Through TEMPO, manufacturers can request enforcement discretion for certain regulatory requirements while collecting real-world data to support future marketing submissions. Manufacturers that submit statements of interest early can expect FDA to begin follow-up requests in March 2026.
In Depth
The TEMPO pilot, developed by FDA’s Center for Devices and Radiological Health, introduces a risk-based enforcement approach for certain digital health devices intended to...
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