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# TEMPO Digital Health Pilot FAQs
- URL: https://www.fdaweb.com/tempo-digital-health-pilot-faqs/
- Published: 2026-05-19T12:00:00.000Z
- Updated: 2026-09-14T13:39:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161166

FDA has published frequently asked questions about the TEMPO (Technology-Enabled Meaningful Patient Outcomes) pilot project, which it has launched with the Centers for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. The [document](https://www.fda.gov/medical-devices/digital-health-center-excellence/tempo-digital-health-devices-pilot-frequently-asked-questions?ref=fdaweb.com) says the TEMPO pilot aims to:

- promote access to certain digital health devices while safeguarding patient safety;
- evaluate a risk-based enforcement approach that supports digital health devices intended to improve patient outcomes in certain conditions; and
- responsibly encourage innovation while collecting real-world evidence to better understand how the devices perform in real-life settings.

Through the pilot, the notice says, manufacturers may ask for FDA enforcement discretion for certain requirements when their device is offered to or by CMMI ACCESS participants for an intended use to improve patient outcomes, to be used in providing care expected to be covered by the CMMI ACCESS model.

FDA says it will work with pilot participants to identify the circumstances when enforcement discretion may be appropriate for that manufacturer’s device.

The FAQs cover eligibility, statement of interest, and selection.