FDA Clearance & Incident Tracker
Tracker
A dated, filterable log of new FDA AI/ML device clearances, recalls, and reported clinical-AI incidents, sourced from FDA's AI-enabled device list, MAUDE reports, and other cited primary sources such as ECRI hazard reports. This is the site's freshness engine: every entry is timestamped, tagged by specialty and clearance pathway, states its sourcing and known limitations (e.g., MAUDE under-reporting, self-reported and unconfirmed incident causation), and links to any existing appraisal covering that device or tool category. Excludes narrative evaluation of evidence quality, which belongs to Appraisals, and excludes editorializing on fault or causation for incident entries.
Sourced from FDA's AI-enabled device list, MAUDE reports, and ECRI-style hazard reporting. MAUDE is self-reported and known to under-report; reported-incident entries do not confirm causation. Full sourcing and limitations are disclosed on Methodology.
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