InferTrust™ FDA Enforcement: Cryptographic Proof for AI/ML Medical Devices
When FDA issues a 483 or orders a recall of your AI device, can you prove what every inference did? InferTrust™ seals the record at the point of computation so your evidence is ready before the inspector arrives.
What InferTrust™ FDA Enforcement Does
InferTrust™ FDA Enforcement creates cryptographically signed decision records for every inference made by AI/ML-based medical devices. This covers SaMD clinical decision support under FDA scrutiny, AI-enabled diagnostic device recall defense, Predetermined Change Control Plan (PCCP) compliance, post-market surveillance monitoring, 510(k) and De Novo submission evidence, and Good Machine Learning Practice (GMLP) documentation.
Key Pain Points Addressed
- FDA 483 observations citing inadequate AI device documentation and version control
- Class I or Class II recalls requiring proof of which model version produced each diagnostic output
- PCCP submissions needing sealed evidence of every model update and retraining event
- Post-market surveillance requiring provable performance records across patient populations
- Edge AI medical devices operating at the point of care with no network connectivity
Decision Actions Captured
- FDA_COMPLIANT: Decision within cleared indications for use and approved operational parameters
- FDA_FLAG: Output triggers a performance or safety concern requiring clinical review
- FDA_NONCONFORMANCE: Decision outside approved parameters with sealed deviation record
- FDA_ESCALATE: Confidence below threshold, routed to qualified clinician per device labeling
- FDA_HOLD: Insufficient input data quality or pending validation checkpoint
Regulatory Frameworks Supported
- FDA 21 CFR Part 820: Quality System Regulation for Medical Devices
- FDA SaMD PCCP: Predetermined Change Control Plan for AI/ML Devices
- GMLP: Good Machine Learning Practice Principles
- IEC 62304: Medical Device Software Lifecycle
- ISO 13485: Medical Device Quality Management Systems
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