FDA’s TEMPO Pilot Fast-Tracks Digital Health Timeline

Launched Dec. 5, 2025, the FDA’s TEMPO pilot lets digital tools enter care early under strict oversight, betting on real-world evidence over delay

18 Dec 2025

A quiet shift is moving through digital health, and it did not arrive with much fanfare. On Dec. 5, 2025, the Food and Drug Administration rolled out TEMPO, a pilot program that hints at a different way software-driven health tools might reach patients.

TEMPO does not scrap FDA approval. It bends the route. The program allows selected digital health devices to be used in real clinical settings before full clearance. Developers get enforcement discretion, but only if they track safety, effectiveness, and patient outcomes as the product is used. Approval still comes later. The journey just starts sooner.

Although often linked to artificial intelligence, TEMPO is broader than that. It covers digital health tools across the board, from chronic disease management to clinical decision support and care coordination software. The FDA seems to be acknowledging what many builders already know. Modern products mix features and data streams that do not fit neatly into old regulatory categories.

The deeper change is philosophical. Instead of leaning almost entirely on long premarket reviews, regulators are putting more weight on real-world performance. How does a product behave in everyday care, with real clinicians and real patients? That question matters more as software becomes central to managing diabetes, heart disease, and mental health, where updates and learning never really stop.

For companies, the appeal is clear. Earlier clinical use can shorten development timelines and calm investors. The cost is accountability. Enforcement discretion comes with strings attached. Developers must show they can monitor outcomes, detect risks quickly, and act before minor problems turn into patient harm. Strong data governance and compliance may matter as much as strong engineering.

TEMPO also aligns with payment experiments from the Center for Medicare and Medicaid Innovation, reinforcing a push toward measurable outcomes and tighter cost control. According to the Federal Register, manufacturers can submit statements of interest starting Jan. 2, 2026.

This is not deregulation. It is regulation tuned to software. If TEMPO succeeds, it could mark the beginning of a faster, more accountable era for digital health.