Summary
FDA selected participants for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. For selected manufacturers, FDA intends to exercise enforcement discretion for specified requirements when their devices are offered to or by ACCESS model participants for the intended uses under evaluation. Participating manufacturers collect, monitor, and report real-world data.
Healthcare Implications
Provides a limited pathway for selected digital-health devices used in care expected to be covered by CMS’s ACCESS model. FDA has not yet evaluated their effectiveness for the pilot intended uses; enforcement discretion depends on the stated participant and use conditions.