Requires a software algorithm device for assisting users in digital pathology -- an in vitro device intended to evaluate acquired scanned pathology images to assist in diagnosis -- to be subject to special control from the U.S. Food and Drug Administration. Those special controls require detailed product labeling; device performance assessments meeting specific standards; a detailed description of the device's software; and a risk management plan, including measures to protect cybersecurity.
Analysis summaries, actor details, and coverage mappings were LLM-classified and may contain errors.
This is a binding federal regulation from the FDA with mandatory requirements and enforcement mechanisms. The regulation uses mandatory language throughout ('must') and establishes special controls that are legally enforceable requirements for Class II medical devices.
The document has good coverage of approximately 5-6 subdomains, with strong focus on AI system security (2.2), lack of capability or robustness (7.3), lack of transparency or interpretability (7.4), and competitive dynamics (6.4). Coverage is concentrated in system safety, security, and technical performance domains.
The document exclusively governs AI use in the Health Care and Social Assistance sector, specifically focusing on diagnostic medical devices for digital pathology. It establishes comprehensive regulatory requirements for software algorithms used in pathology diagnosis.
The document comprehensively covers multiple AI lifecycle stages with primary focus on Build and Use Model, Verify and Validate, Deploy, and Operate and Monitor stages. It provides detailed requirements for software development, training data, validation testing, labeling, and ongoing risk management.
The document explicitly covers AI systems and software algorithms for digital pathology. It focuses on task-specific AI for medical diagnosis assistance. There is no mention of frontier AI, general purpose AI, foundation models, generative AI, or compute thresholds. The document addresses predictive AI in the context of diagnostic assistance.
Food and Drug Administration (FDA)
The document is a federal regulation issued by the FDA under Title 21 of the Code of Federal Regulations, establishing special controls for software algorithm devices in digital pathology.
Food and Drug Administration (FDA)
The FDA has authority to enforce compliance with these special controls, including determining acceptable performance standards and ensuring regulatory compliance for Class II medical devices.
Food and Drug Administration (FDA)
The FDA monitors compliance through review of device performance data, validation studies, and ongoing oversight of Class II medical devices under its regulatory authority.
Manufacturers and deployers of software algorithm devices for digital pathology
The regulation applies to entities that develop, manufacture, and deploy software algorithm devices intended to assist users in digital pathology diagnosis. These are Class II medical devices subject to special controls.
6 subdomains (4 Good, 2 Minimal)