A New Digital Health Regulatory Pathway: FDA TEMPO Model
The digital health regulatory pathway has entered a significant new pilot phase with the FDA’s Technology-Enabled Meaningful Patient Outcomes (TEMPO) initiative. Launched on December 5, 2025, by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot is designed to increase responsible access to digital health technologies used in chronic disease management. Some of […]
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