FDA’s TEMPO Pilot Seeks to Expand Access to Chronic Disease Technologies in CMS Collaboration

On December 5, 2025, FDA announced its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a new voluntary pilot that seeks to accelerate innovation and expand access to digital health devices for people living with chronic conditions. Under TEMPO, FDA will evaluate a new, risk-based enforcement approach that supports digital health devices intended for……
By: Akin Gump Strauss Hauer & Feld LLP