FDA Launches TEMPO Pilot to Improve Patient Access to Digital Health Devices

The initiative, led by the FDA’s Center for Devices and Radiological Health (CDRH), introduces a risk-based enforcement approach aligned with the rapid development cycle of digital health technologies.

The US Food and Drug Administration (FDA) has launched Technology-Enabled Meaningful Patient Outcomes (TEMPO), a digital health pilot programme aimed at expanding patient access to devices used in chronic disease management.

The initiative, led by the FDA’s Center for Devices and Radiological Health (CDRH), introduces a risk-based enforcement approach aligned with the rapid development cycle of digital health technologies.

Set to begin in January 2026, the FDA is seeking around ten manufacturers to participate in the pilot. Eligible devices must support the management of cardiometabolic conditions, complex cardiometabolic disorders, musculoskeletal issues, or behavioural health conditions — areas where digital tools have seen accelerated adoption and growing clinical relevance.

Under the TEMPO framework, the FDA may exercise enforcement discretion for requirements such as premarket authorisation or investigational device exemptions. Participating manufacturers will collect and share real-world performance data as patients use their devices in everyday settings. The FDA aims to assess when such discretionary measures are appropriate, with the broader objective of improving access without compromising patient safety.

CDRH director Michelle Tarver said digital health technologies are reshaping chronic disease management and emphasised the need for regulatory models that evolve alongside technological advances. She noted that the pilot will help the agency gather real-world evidence to better understand device performance.

The programme is also aligned with the Centers for Medicare and Medicaid Services’ (CMS) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. Devices offered by participating manufacturers will be used within ACCESS-covered care provisions, enabling Medicare-Medicaid beneficiaries to receive technology-enabled, integrated care while generating real-world data.

FDA commissioner Marty Makary said the initiative is intended to support digital tools that meet patients where they are and strengthen care delivery models for people managing chronic diseases.

The TEMPO pilot is expected to shape future regulatory approaches for digital health, especially in high-burden disease areas where timely access to innovative tools can significantly influence care outcomes.

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