The US Food and Drug Administration (FDA) has launched Technology-Enabled Meaningful Patient Outcomes (TEMPO), a pilot that aims to promote patient access to certain digital health devices.
TEMPO has been developed by the FDA’s Center for Devices and Radiological Health (CDRH) and is being undertaken to evaluate a new, risk-based enforcement approach to support patient access to digital health devices.
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Due to begin in January 2026, the FDA is seeking around ten manufacturers to participate in the TEMPO pilot. Chosen participants’ devices must apply to the management of cardiometabolic conditions, complex cardiometabolic conditions, musculoskeletal issues, or behavioural health conditions.
The scheme will allow the FDA to exercise enforcement discretion for regulatory dictates such as premarket authorisation and investigational device requirements as manufacturers collect and share real-world data demonstrating a device’s performance.
By working with participants in the TEMPO pilot to identify the circumstances when enforcement discretion may be appropriate, the FDA said the pilot’s purpose is to align with the “rapid and iterative nature” of digital health development and expand patient access to innovative technologies.
CDRH director Michelle Tarver commented: “Digital health technologies are rapidly transforming how people manage chronic conditions, and we want to ensure our regulatory approach keeps pace.
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By GlobalData“The TEMPO pilot will allow us to responsibly encourage innovation while collecting real-world evidence that may help us better understand how these devices perform for patients in their everyday lives.”
The TEMPO pilot also aligns with the US Centers for Medicare and Medicaid Services’ (CMS) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model.
Participating manufacturers in the pilot will offer their devices for care provisions covered by ACCESS, an initiative that aims to increase Medicare-Medicaid beneficiaries’ access to technology-enabled, integrated care, while collecting, monitoring, and reporting real-world performance data.
FDA commissioner Marty Makary explained: “We are piloting an approach to encourage the use of digital technologies that meet people where they are.
“This pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.”
