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FDA explains Tempo pilot and collaborative approach with CMS for device data and clinical AI
Summary
Dr. Michelle Tarver of the FDA described the Tempo pilot and FDA’s use of enforcement discretion to collect real-world evidence for certain low-risk devices while collaborating with CMS to align evidence and market access pathways.
Dr. Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health, said FDA is working with CMS and HHS to collect device and clinical-AI evidence through the Tempo pilot. "We are exercising enforcement discretion for some of those technologies while they are collecting the data in use as part of the access program," she said, describing the pilot as a novel, whole-of-government approach.
Tarver said the FDA’s role is to evaluate safety and effectiveness and to be an arbitrator of evidence developed in the pilot while seeking to reduce burdens for innovators where appropriate. She described Tempo as a unique approach that pairs data collection with regulatory review and emphasized the need for collaboration to produce trustworthy evidence that can inform care.
Her remarks framed the FDA’s participation as both protective of patients and enabling of innovation, and she encouraged developers to engage with the pilot’s evidence-generation pathways.
