21 CFR § 882.1491 ("Pediatric Autism Spectrum Disorder diagnosis aid")

• Authority: Food and Drug Administration
• Parent authority: Federal government
• Jurisdiction: United States
• Collections: U.S. regulations, executive orders, and agency policies
• Most recent activity: Enacted
• Most recent activity date: 2022-12-30

Risk subdomain coverage

Minimal coverage — Brief mention but no specific mitigations, recommendations or governance measures relating to the risk subdomain are described.

• Unequal performance across groups
• AI system security vulnerabilities

All other risk subdomains had no coverage in this document.

Risk Coverage Summary

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.

Sector coverage

Good coverage — Comprehensive governance measures or mitigations with clear procedures relating to the sector are explicitly described.

• Health Care & Social Assistance

Minimal coverage — Brief mention but no specific mitigations, recommendations or governance measures relating to the sector are described.

• Professional & Technical Services
• Scientific Research & Development Services

All other sectors had no coverage in this document.

Sectors Summary

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.

Legislative Status

Hard Law

Legislative Status Summary

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.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: 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.

Target

• Entity Types: AI_Developer, AI_Deployer
• Entities: Manufacturers and deployers of pediatric Autism Spectrum Disorder diagnosis aid devices
• Summary: 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.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: 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.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: 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.

AI Lifecycle Stages

Lifecycle stages covered by the documents, as defined in the OECD Framework for the Classification of AI Systems

• Plan and Design
• Build and Use Model
• Verify and Validate
• Deploy
• Operate and Monitor

AI Lifecycle Summary

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.

Technical Scope

Terms relating to technical scope that are mentioned or implicitly referenced in the document

• AI Models
• AI Systems
• Predictive AI
• Task-specific AI

Technical Scope Summary

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.