Requires performance testing and disclosure of image analysis algorithms used in medical image analyzers that help detect abnormalities during a patient radiograph.
Analysis summaries, actor details, and coverage mappings were LLM-classified and may contain errors.
This is a binding federal regulation from the Code of Federal Regulations (CFR) with mandatory requirements for medical device manufacturers, enforced by the FDA with legal penalties for non-compliance.
The document has minimal coverage of approximately 2-3 subdomains, with focus on AI system safety failures (7.3 Lack of robustness, 7.4 Lack of transparency) and minimal coverage of discrimination risks (1.3 Unequal performance). Coverage is concentrated in technical reliability and transparency requirements for medical imaging AI systems.
The document exclusively governs AI use in the Health Care and Social Assistance sector, specifically focusing on medical imaging and radiology services. It regulates medical image analyzers used in clinical settings for detecting abnormalities in patient radiographs.
The document comprehensively covers the Build and Use Model, Verify and Validate, and Deploy stages with detailed requirements for algorithm development, performance testing, and labeling. It also addresses aspects of Plan and Design through algorithm specification requirements, and Operate and Monitor through performance characterization and limitation disclosure requirements.
The document explicitly covers AI systems (medical image analyzers) and AI models (image analysis algorithms) with detailed requirements. It addresses task-specific/narrow AI for medical image analysis and predictive AI for abnormality detection. No mention of frontier AI, general purpose AI, foundation models, generative AI, open-weight models, or compute thresholds.
Food and Drug Administration (FDA)
The document is part of Title 21 of the Code of Federal Regulations, which contains FDA regulations. The FDA has statutory authority to regulate medical devices under the Federal Food, Drug, and Cosmetic Act.
Food and Drug Administration (FDA)
The FDA has enforcement authority over medical devices through its regulatory powers, including pre-market clearance requirements, post-market surveillance, and enforcement actions for non-compliance with CFR requirements.
Food and Drug Administration (FDA)
The FDA monitors compliance with medical device regulations through pre-market review processes, post-market surveillance systems, and ongoing oversight of device performance and safety.
The regulation applies to manufacturers and developers of medical image analyzers (AI developers) and healthcare providers who use these devices as prescription devices (AI deployers). The document specifies requirements for device design, validation, and labeling that apply to manufacturers, while also regulating clinical use.
4 subdomains (2 Good, 2 Minimal)