21 CFR § 870.1345 ("Intravascular bleed monitor")

• 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: 2022-06-08

Risk subdomain coverage

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

• 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.

• AI system security vulnerabilities

All other risk subdomains had no coverage in this document.

Risk Coverage Summary

The document has good coverage of approximately 3-4 subdomains, with strong focus on AI system safety and robustness (7.3), lack of transparency (7.4), and human-computer interaction risks related to overreliance (5.1). Coverage is concentrated in technical safety, validation, and usability 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

All other sectors had no coverage in this document.

Sectors Summary

The document exclusively governs the Health Care and Social Assistance sector, specifically regulating medical devices used for detecting and monitoring internal bleeding complications. This is a sector-specific medical device regulation with comprehensive technical and safety requirements.

Legislative Status

Hard Law

Legislative Status Summary

This is a binding federal regulation from the Code of Federal Regulations (CFR) with mandatory requirements enforced by the FDA, using mandatory language throughout and establishing specific controls that manufacturers must comply with.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Entities: U.S. Food and Drug Administration (FDA)
• Summary: The document is a federal regulation (21 CFR § 870.1345) issued by the FDA, which 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 intravascular bleed monitors
• Summary: The regulation applies to manufacturers who develop and seek to market intravascular bleed monitors that use algorithms to detect internal bleeding. These entities must comply with the special controls before receiving FDA clearance.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: U.S. Food and Drug Administration (FDA)
• Summary: The FDA has enforcement authority over medical device manufacturers to ensure compliance with the special controls outlined in this regulation, including pre-market review and post-market surveillance.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: U.S. Food and Drug Administration (FDA)
• Summary: The FDA monitors compliance through pre-market review of performance data and post-market surveillance of device safety and effectiveness.

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 comprehensively covers verification and validation, deployment preparation, and operational monitoring stages. It focuses heavily on testing requirements (in vivo and non-clinical), software validation, and labeling for safe deployment and use.

Technical Scope

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

• Predictive AI
• Task-specific AI

Technical Scope Summary

The document explicitly mentions an AI algorithm used for detecting and monitoring internal bleeding. It does not use terms like 'AI system' or 'AI model' but clearly regulates a medical device that incorporates algorithmic decision-making. No specific AI categories (frontier, GPAI, generative, etc.) or compute thresholds are mentioned.