21 CFR § 870.1420 ("Coronary artery disease risk indicator using acoustic heart signals")

• 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: 2022-06-01

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
• Overreliance and unsafe use

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 technical robustness (7.3, 7.4), human-computer interaction risks (5.1), and unequal performance across groups (1.3). Coverage is concentrated in system safety, transparency, and performance reliability domains relevant 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.

• Agriculture, Mining, Construction & Manufacturing
• 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 cardiac diagnosis and risk assessment. It also has secondary relevance to Scientific Research and Development Services through its requirements for clinical testing and algorithm validation.

Legislative Status

Hard Law

Legislative Status Summary

This is a binding federal regulation from the FDA (21 CFR) establishing mandatory special controls for Class II medical devices, with clear enforcement authority and legal obligations.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: The document is a federal regulation (21 CFR § 870.1420) issued by the FDA under its statutory authority to regulate medical devices. The FDA is the regulatory agency that proposed and established these special controls for Class II medical devices.

Target

• Entity Types: AI_Developer, AI_Deployer
• Entities: Manufacturers of coronary artery disease risk indicator devices using acoustic heart signals
• Summary: The regulation applies to entities that develop and manufacture AI-based medical devices that use acoustic heart signals to calculate coronary artery disease risk. These entities must comply with the special controls before marketing such devices.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: The FDA has enforcement authority over medical device manufacturers to ensure compliance with these special controls through its premarket review process, inspections, and post-market surveillance authority.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: The FDA monitors compliance with these requirements through premarket submissions review, post-market surveillance, and inspection of manufacturing facilities to ensure ongoing 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, and operation/monitoring stages. It requires extensive testing, algorithm validation, and performance demonstration before deployment, plus labeling requirements for ongoing use. It also addresses design considerations through algorithm justification 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 addresses AI algorithms used in medical devices for calculating patient-specific coronary artery disease risk. It focuses on task-specific predictive AI systems rather than general-purpose or generative AI. No compute thresholds or open-source model considerations are mentioned.