Requires manufacturers of radiological computer-assisted diagnostic software to disclose image analysis algorithm details, performance testing protocols and results, and software limitations.
Analysis summaries, actor details, and coverage mappings were LLM-classified and may contain errors.
This is a binding federal regulation under the Code of Federal Regulations (CFR) with mandatory requirements for manufacturers of radiological computer-assisted diagnostic software, enforced by the FDA with legal penalties for non-compliance.
The document has good coverage of approximately 3-4 subdomains, with strong focus on AI system safety failures (7.3, 7.4), unequal performance across groups (1.3), and governance failure prevention (6.5). Coverage is concentrated in system reliability, transparency, and performance equity domains.
The document primarily governs the Health Care and Social Assistance sector, specifically regulating AI-based medical diagnostic devices used in radiological imaging for cancer detection. It also has secondary coverage of the Information sector through regulation of software development and the Scientific Research and Development Services sector through performance testing requirements.
The document comprehensively covers multiple AI lifecycle stages with primary focus on Build and Use Model, Verify and Validate, and Deploy stages. It requires detailed algorithm documentation, performance testing, and validation protocols. The regulation also addresses ongoing monitoring through labeling requirements that specify performance limitations and failure conditions.
The document explicitly addresses AI systems (radiological computer-assisted diagnostic software) and AI models (image analysis algorithms). It focuses on task-specific/narrow AI for medical image analysis and predictive AI for lesion characterization. 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 a federal regulation (21 CFR § 892.2060) issued by the FDA, which 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 device regulations through its statutory powers, including pre-market review, post-market surveillance, and enforcement actions for non-compliance with CFR requirements.
Food and Drug Administration (FDA)
The FDA monitors compliance through its medical device regulatory framework, including review of performance testing protocols, software documentation, and post-market surveillance of device performance.
Manufacturers of radiological computer-assisted diagnostic software for lesions suspicious of cancer
The regulation explicitly targets manufacturers who develop and seek to market radiological computer-assisted diagnostic software. These entities must comply with design verification, validation, and labeling requirements.
5 subdomains (4 Good, 1 Minimal)