21 CFR § 864.3750 ("Adjunctive hemodynamic indicator with decision point")

• 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: 2022-12-27

Risk subdomain coverage

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

• False or misleading information
• Overreliance and unsafe use
• 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
• Compromise of privacy
• AI system security vulnerabilities
• Loss of human agency and autonomy

All other risk subdomains had no coverage in this document.

Risk Coverage Summary

This document primarily addresses AI system safety, failures, and limitations (domain 7), with strong focus on lack of robustness (7.3) and lack of transparency (7.4). It also touches on privacy and security concerns (domain 2) through data quality requirements, and human-computer interaction risks (domain 5) through usability and overreliance mitigation.

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 device manufacturers and healthcare providers using AI-based hemodynamic monitoring devices. The regulation does not apply to other sectors.

Legislative Status

Hard Law

Legislative Status Summary

This is a binding federal regulation from the Code of Federal Regulations (CFR) issued by the FDA with mandatory compliance requirements and enforcement mechanisms.

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 administered by the FDA. The FDA has statutory authority to regulate medical devices under the Federal Food, Drug, and Cosmetic Act.

Target

• Entity Types: AI_Developer, AI_Deployer
• Entities: Manufacturers of adjunctive hemodynamic indicator devices with decision points
• Summary: The regulation applies to entities that develop and manufacture medical devices that monitor hemodynamic conditions. These entities must comply with the special controls outlined, including software validation, clinical data requirements, and labeling specifications.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: The FDA has enforcement authority over medical devices classified under 21 CFR. The agency conducts pre-market reviews, inspections, and can take enforcement actions for non-compliance with device regulations.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: The FDA monitors compliance with medical device regulations through pre-market submissions, post-market surveillance, and inspection programs. The special controls require ongoing validation and clinical data that would be subject to FDA review.

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 multiple AI lifecycle stages with particular emphasis on Verify and Validate, Deploy, and Operate and Monitor stages. It requires extensive validation testing, clinical data, and ongoing performance monitoring for hemodynamic indicator devices.

Technical Scope

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

• AI Systems
• Predictive AI
• Task-specific AI

Technical Scope Summary

The document explicitly addresses AI systems (hemodynamic indicator devices) and algorithms but does not use terminology like 'AI models', 'frontier AI', 'GPAI', or 'foundation models'. It focuses on task-specific predictive AI for medical monitoring without mentioning compute thresholds or open-source models.