FDA Seeks Statements Of Interest For TEMPO Digital Health Devices Pilot For Those With Chronic Disease

The Food and Drug Administration (FDA) announced it is seeking statements of interest for participation in its TEMPO (Technology-Enabled Meaningful Patient Outcomes) pilot for digital health devices beginning in January 2026.

The FDA plans to select up to 10 manufacturers in each of four specific clinical use areas to participate. The voluntary pilot is designed to promote access to certain digital health devices while safeguarding patient safety. The four clinical use areas are early cardio-kidney-metabolic conditions (eCKM); cardio-kidney-metabolic conditions (CKM); musculoskeletal conditions (MSK); and behavioral health conditions (depression and anxiety).

“The TEMPO pilot marks a . . .