Requires testing that demonstrates photoplethysmograph analysis software is accurate and adequate for detecting irregular heart rhythms.
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 and enforcement mechanisms through the FDA.
The document has minimal coverage of approximately 2-3 subdomains, with focus on AI system safety failures (7.3 Lack of robustness) and human-computer interaction risks (5.1 Overreliance and unsafe use). Coverage is concentrated in technical reliability and user interaction safety domains, reflecting the medical device regulatory context.
This regulation primarily governs the Health Care and Social Assistance sector, specifically medical device manufacturers developing AI-based diagnostic support tools. It also has implications for the Information sector (software developers) and Scientific Research and Development Services (algorithm development and testing).
The document covers multiple AI lifecycle stages with primary focus on Verify and Validate, Deploy, and Operate and Monitor stages. It mandates clinical and non-clinical performance testing, software verification and validation, human factors testing, and labeling requirements that span from pre-deployment validation through operational monitoring.
The document explicitly covers AI systems (photoplethysmograph analysis software) and AI models (detection algorithm) in a task-specific medical application. It does not mention frontier AI, general purpose AI, foundation models, generative AI, or compute thresholds. The focus is on predictive/analytical AI for a narrow medical purpose.
Food and Drug Administration (FDA)
The document is a regulation from 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, including the authority to conduct pre-market reviews, post-market surveillance, and take enforcement actions for non-compliance with regulations.
Food and Drug Administration (FDA)
The FDA monitors compliance with medical device regulations through pre-market review processes, post-market surveillance systems, and ongoing oversight of device performance and safety.
The regulation applies to manufacturers and developers of photoplethysmograph analysis software devices for over-the-counter use, who must comply with the special controls before marketing such devices. These entities both develop the AI algorithms and deploy them as medical devices.
3 subdomains (2 Good, 1 Minimal)