Classifies a machine-learning software program and device used in the diagnosis of Autism Spectrum Disorder into the U.S. Food and Drug Administration's class II, which mandates clinical performance testing; software verification, validation, and hazard analysis; usability assessment; and detailed product labeling.
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. It uses mandatory language throughout ('must') and establishes legally enforceable special controls for Class II medical devices.
The document has minimal coverage of approximately 3-4 subdomains, with focus on AI system safety and reliability (7.3), unequal performance across groups (1.3), and governance failure prevention (6.5). Coverage is concentrated in system safety, technical robustness, and basic fairness considerations specific to medical device regulation.
The document primarily governs the Health Care and Social Assistance sector, specifically regulating AI-based medical devices used for pediatric Autism Spectrum Disorder diagnosis. It also has secondary relevance to Scientific Research and Development Services and Professional and Technical Services sectors involved in developing and validating such diagnostic tools.
The document covers multiple AI lifecycle stages with primary focus on Verify and Validate, Deploy, and Operate and Monitor stages. It mandates clinical performance testing, software verification and validation, usability assessment, and detailed labeling requirements. The regulation also addresses design considerations through algorithm documentation requirements.
The document explicitly covers AI systems (the diagnosis aid device) and machine-learning software programs. It is task-specific AI designed for pediatric Autism Spectrum Disorder diagnosis. There is no mention of frontier AI, general purpose AI, foundation models, generative AI, or compute thresholds.
Food and Drug Administration (FDA)
The document is a federal regulation (21 CFR § 882.1491) issued by the FDA under its statutory authority to regulate medical devices. The FDA is the regulatory agency that proposed and established this classification.
Food and Drug Administration (FDA)
The FDA has enforcement authority over medical devices through premarket review, post-market surveillance, and enforcement actions. As the issuing regulatory agency, the FDA enforces compliance with the special controls specified in this regulation.
Food and Drug Administration (FDA)
The FDA monitors compliance through its medical device regulatory framework, including review of clinical performance testing, software validation, and labeling requirements. The agency conducts post-market surveillance of Class II devices.
Manufacturers and deployers of pediatric Autism Spectrum Disorder diagnosis aid devices
The regulation applies to entities that develop, manufacture, and deploy machine-learning software programs and devices used in diagnosing Autism Spectrum Disorder in pediatric patients. These entities must comply with the special controls outlined.
2 subdomains (2 Minimal)