Requires that an intravascular bleed monitor -- which uses measurements of the body's electrical conductivity and an algorithm to monitor potential internal bleeding complications -- be subject to special controls from the U.S. Food and Drug Administration. Those controls require performance testing for efficacy, usability, and safety; software verification, validation, and hazard analysis; and detailed labeling.
Analysis summaries, actor details, and coverage mappings were LLM-classified and may contain errors.
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.
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.
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.
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.
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.
U.S. Food and Drug Administration (FDA)
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.
U.S. Food and Drug Administration (FDA)
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.
U.S. Food and Drug Administration (FDA)
The FDA monitors compliance through pre-market review of performance data and post-market surveillance of device safety and effectiveness.
Manufacturers of intravascular bleed monitors
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.
4 subdomains (3 Good, 1 Minimal)