Requires disclosure and verification of algorithms used in coronary artery disease risk indicators to calculate a patient-specific risk of presence of coronary artery disease.
Analysis summaries, actor details, and coverage mappings were LLM-classified and may contain errors.
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.
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.
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.
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.
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.
Food and Drug Administration (FDA)
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.
Food and Drug Administration (FDA)
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.
Food and Drug Administration (FDA)
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.
Manufacturers of coronary artery disease risk indicator devices using acoustic heart signals
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.
4 subdomains (2 Good, 2 Minimal)