Regulation
FDA Cures Act non-device CDS
US carve-out exempting transparent clinical decision support from FDA device regulation.
Under the 21st Century Cures Act (21 USC § 360j(o)) and FDA's implementing guidance, certain clinical decision-support software is excluded from device regulation if it meets four criteria — notably that it lets the clinician *independently review the basis* for the recommendation. FDA narrowed the exemption in 2022 and then broadened enforcement discretion again in 2026.
This is the structural reason a US-born clinical-decision tool faces a much lighter regulatory path than its EU equivalent under MDR Rule 11.
See also
- EU MDR (Regulation 2017/745) — EU Medical Device Regulation — governs healthcare software that has a medical purpose.
- Annex VIII, Rule 11 (EU MDR) — The MDR rule that classifies decision-informing healthcare software as a regulated device.