FDA on December 8, 2025 opened a pilot in which it will not enforce premarket authorization or IDE requirements for selected digital health devices used inside the CMS Innovation Center's ACCESS model. Devices must be intended for clinician-supervised outpatient treatment in one of four areas: early cardio-kidney-metabolic conditions such as hypertension, dyslipidemia, obesity and prediabetes; established cardio-kidney-metabolic disease including diabetes, chronic kidney disease and atherosclerotic cardiovascular disease; chronic musculoskeletal pain; and depression or anxiety.
Eligibility is narrow in ways that matter. The manufacturer must be based in the United States with a federal tax ID and keep quality management records at an FDA-registered U.S. facility. The device must be unlikely to present a serious risk to health, and one that already holds marketing authorization does not qualify. Participants commit to a real-world performance data plan, interim reports every six months covering adverse events and progress, and a timeline for filing a 510(k), De Novo or PMA built on the pilot data.
Statements of interest opened January 2, 2026, with FDA follow-ups expected around March 2. CDRH Director Michelle Tarver said the design lets the agency "responsibly encourage innovation while collecting real-world evidence."
For a prescription digital therapeutic company facing two years of confirmatory trials before its first dollar of revenue, an enforcement discretion window tied to a paying Medicare model is a different business plan. The catch is that FDA has not evaluated effectiveness for any device in the pilot, and says so publicly on the participant list.