21 CFR § 870.2210 ("Adjunctive predictive cardiovascular indicator")

• 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: 2022-02-14

Risk subdomain coverage

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

• Unfair discrimination and misrepresentation
• Unequal performance across groups
• 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.

• False or misleading information
• Overreliance and unsafe use

All other risk subdomains had no coverage in this document.

Risk Coverage Summary

The document has good coverage of approximately 4-5 subdomains, with strong focus on AI system safety and reliability (7.3), lack of transparency (7.4), unequal performance across groups (1.3), and unfair discrimination (1.1). Coverage is concentrated in system safety, performance equity, and transparency domains relevant to medical AI devices.

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

This regulation exclusively governs the Health Care and Social Assistance sector, specifically medical devices used in cardiovascular care. It establishes special controls for AI-based predictive cardiovascular indicators used in clinical settings.

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: This regulation is part of Title 21 of the Code of Federal Regulations, which is promulgated by the FDA under its statutory authority to regulate medical devices.

Target

• Entity Types: AI_Developer, AI_Deployer
• Summary: The regulation applies to manufacturers and deployers of adjunctive predictive cardiovascular indicator devices that use software algorithms. These entities must provide verification, validation, clinical assessments, and labeling as specified in the special controls.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: The FDA has enforcement authority over medical devices under the Federal Food, Drug, and Cosmetic Act. As the regulatory agency that promulgated this regulation, the FDA enforces compliance with these special controls.

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, and inspection of manufacturing facilities to ensure adherence to special controls.

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 verification and validation, deployment requirements, and operational monitoring stages. It addresses the entire lifecycle from design through post-market use, with particular emphasis on testing, clinical validation, and ongoing performance monitoring across diverse populations.

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 addresses AI systems (specifically predictive cardiovascular indicator devices using software algorithms) and AI models (the algorithms themselves). It focuses on task-specific predictive AI for cardiovascular health prediction. No mention of frontier AI, general purpose AI, foundation models, generative AI, open-weight models, or compute thresholds.