FDA narrows premarket review for clinical decision support

US-FEDMAJORGuidanceHealthcare AIClinical decision support

Revised guidance let single-recommendation CDS proceed under enforcement discretion where clinicians can independently review the logic — transferring the evidentiary burden from agency to organization.

Source: FDA guidance — read in the original, not from coverage.

Permanent record: this page is public forever. "When did we know?" always has a URL.

Curated nightly by Dr. Ivan Del Valle — AI governance architect, editor of The Compact. Disagree with a reading? Write ivan.delvalle@rsit.ai — every message is read, most are answered. Corrections are published, not buried. · Today's brief · Method · Reporting free forever; the desk is sustained by its data plans.