If a device is not authorized for the proposed intended use, manufacturers may request that FDA exercise enforcement discretion over the device while participating in the pilot program.
The U.S. Food and Drug Administration (FDA) has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA would exercise enforcement discretion over participant manufacturers’ digital health devices to improve patient access to digital health technologies. See 90 Fed. Reg. 56768 (Dec. 8, 2025). By exercising enforcement discretion, FDA would allow device manufacturers to forego certain marketing requirements, such as labeling and premarket authorization, while participating in the pilot program. FDA considers the TEMPO pilot a key component of its Home as a Health Care Hub initiative, which aims to incorporate point of care and wearable medical devices into the home to promote health and wellness.
Pilot participants may offer their devices for use in conjunction with the Center for Medicare and Medicaid Innovation’s Advancing Chronic Care with Effective Scalable Solutions (CMMI ACCESS) payment model. The CMMI ACCESS model introduces outcomes-based payments for improvement of patients’ chronic health conditions. To support patient access to digital health, participant manufacturers may offer a device for an intended use to support patient outcomes and for use in providing care that is expected to be covered under the CMMI ACCESS model. If a device is not authorized for the proposed intended use, manufacturers may request that FDA exercise enforcement discretion over the device while participating in the pilot program.
That said, manufacturers selected for the TEMPO pilot are expected to collect real-world data relating to the intended use. Manufacturers may use such data to generate real-world evidence and support an application for marketing authorization.
In sum, participant manufacturers in the TEMPO pilot would have a device, as defined under the federal Food, Drug, and Cosmetic Act, Section 201(h), that:
- Is offered for an intended use to improve patient outcomes such as measurable changes in chronic disease outcomes;
- Does not pose a potential for serious risk to patient health, safety or welfare;
- Meets one of four clinical use areas in the CMMI ACCESS model: early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal or behavioral health; and
- Is offered to a CMMI ACCESS model organization or, if the manufacturer is a CMMI ACCESS model organization, for use by an CMMI ACCESS model organization.
FDA has also indicated that it intends to select manufacturers based in the United States to facilitate oversight and inspections.
As of January 2, 2026, FDA is accepting by email statements of interest from manufacturers interested in participating in the TEMPO pilot. Requests should include proposed indications for use identifying the intended use to improve patient outcomes in a clinical use area from the four CMMI ACCESS model areas, manufacturer name and device description, any current authorizations or prior FDA interactions related to the device and, if applicable, request for enforcement discretion.
FDA may request additional information such as a device and intended use description, data to support the device’s patient benefit and risk-profile, information about the manufacturer’s quality management system, a plan to mitigate patient risk and outline real world data collection, performance goals and statistical planning for patient outcomes, a timeline for data collection and marketing submission and, lastly, an interim reporting plan.
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