21 CFR § 892.2070 ("Medical image analyzer")

• 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: 2020-02-21

Risk subdomain coverage

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

• Lack of capability or robustness
• Lack of transparency or interpretability

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 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.

Sector coverage

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

• Health Care & Social Assistance

All other sectors had no coverage in this document.

Sectors Summary

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.

Legislative Status

Hard Law

Legislative Status Summary

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.

Actors

Proposer

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

Target

• Entity Types: AI_Developer, AI_Deployer
• Summary: 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.

Enforcer

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

Monitor

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

AI Lifecycle Stages

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

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

AI Lifecycle Summary

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.

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 (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.