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.
EntryPredetermined Change Control Plan (PCCP): What the FDA's August 2025 Final Guidance Actually Requires of Manufacturers
EntryFDA's Predetermined Change Control Plan Guidance: What It Requires and Why It Matters for Health Systems
EntryFDA's January 2025 Draft Guidance on AI-Enabled Device Software Functions: Nine Documentation Requirements and What They Mean for Submissions
EntryTEFCA, FHIR, and Clinical AI: What ONC's Interoperability Infrastructure Means for AI Development and Deployment
EntryNIST AI Risk Management Framework in Healthcare: How GOVERN, MAP, MEASURE, and MANAGE Bridge FDA Voluntary Governance and Algorithmic Accountability
EntryAI Dermatology Tools and Skin Tone Bias: The Evidence Base, Root Causes, and Remediation Strategies
EntryAI in Medicine: How the U.S. Regulatory Framework Actually Works
EntryMitigating Algorithmic Bias in Safety-Net Clinical AI: Lessons from NYC Health + Hospitals
EntryArtificial Intelligence and Health: The U.S. Regulatory Framework in 2026
EntryArtificial Intelligence in Health: The Regulatory Landscape in 2026
EntryCMS Prior Authorization and AI: How Three Federal Rules Are Reshaping Utilization Management
EntryFDA AI/ML SaMD Action Plan (2021): Five Commitments, Key Deliverables, and Implementation Status Through Q2 2026
EntryFDA PCCP Guidance for AI-Enabled Devices: Document Record, Version History, and Current Status (Q2 2026)
EntryFDA Predetermined Change Control Plan for AI/ML Medical Devices
EntryONC Information Blocking Rule: What It Means for AI Systems, Agentic Workflows, and Healthcare Data Access
RecallPumpkin Tree Peter Rabbit Organics Banana Strawberry Fruit Puree PouchesPediatricsClass IINew
RecallMidwest Poultry Services Shell EggsInfectious DiseaseUnclassifiedNew