Requires assessments of the risks and efficacy of algorithms used in adjunctive predictive cardiovascular indicators to analyze cardiovascular vital signs and predict future cardiovascular health.
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 for medical device manufacturers, enforced by the FDA with legal penalties for non-compliance.
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.
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.
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.
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.
Food and Drug Administration (FDA)
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.
Food and Drug Administration (FDA)
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.
Food and Drug Administration (FDA)
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.
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.
6 subdomains (4 Good, 2 Minimal)