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FDA describes 'Tempo' pilot with CMS as novel evidence pathway for low‑risk devices and AI
Summary
FDA's Center for Devices and Radiological Health described the Tempo pilot that collects real-world evidence with FDA enforcement discretion for certain low-risk technologies working with CMS access models.
Michelle Tarver (S9), director of the FDA Center for Devices and Radiological Health, told the event that the Tempo program is an experimental pathway in which some low-risk device- or software-based technologies collect real-world evidence while FDA exercises enforcement discretion. The pilot's first participant was announced recently, and Tarver described Tempo as a whole-of-government collaboration with CMS to test evidence-generation approaches for devices and AI-enabled tools.
Tarver said the pilot balances safety and innovation: "We are a key element to trust, we're a key element of evidence, and a key arbitrator of that evidence," she said, adding that innovators want predictable, proportionate requirements. She stressed that integration between data, devices, and clinical workflows matters and that regulatory burden should be calibrated to risk and evidence needs.
