An overview of the FDA regulatory framework for AI/ML-based medical devices, including 21 CFR Part 820, SaMD PCCP, GMLP, and how InferTrust™ supports compliance
AI/ML-based medical devices fall under multiple overlapping FDA regulatory requirements. Understanding this framework is essential for manufacturers building AI decision integrity infrastructure. InferTrust™ FDA Enforcement (Patent Pending) is designed to support compliance across the full regulatory landscape.
The Quality System Regulation applies to all medical device manufacturers, including those producing AI/ML-based devices. For AI devices, Part 820 requirements include design controls that document algorithm development and validation (820.30), production and process controls for software deployment (820.70 and 820.75), corrective and preventive action procedures for algorithm failures (820.90), and records requirements for all quality system activities (820.180 and 820.184). InferTrust™ decision records support Part 820 compliance by providing tamper-evident documentation of design validation, deployment events, and ongoing performance monitoring.
FDA's PCCP framework allows manufacturers to pre-specify the types of algorithm changes they plan to make, the methodologies for implementing those changes, and the performance criteria for evaluating them. InferTrust™ seals every model update, retraining event, and threshold adjustment into the decision chain, creating the verifiable evidence that PCCP compliance requires. When FDA reviews PCCP adherence during an inspection, the cryptographic record chain proves that every change followed the approved protocol.
FDA, Health Canada, and the UK MHRA jointly published guiding principles for GMLP. These principles address data management, model training, validation, deployment, and monitoring. While GMLP principles are not legally binding regulations, they represent FDA's expectations for AI device manufacturers. InferTrust™ supports GMLP adherence by creating sealed records for training data provenance, validation testing, performance monitoring, and change control activities.
IEC 62304 governs medical device software lifecycle processes, ISO 13485 covers quality management systems, and ISO 14971 addresses risk management. InferTrust™ decision records provide the verifiable documentation layer that supports compliance across all three standards, particularly for software version control (IEC 62304), design and development records (ISO 13485), and risk control verification (ISO 14971).