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