Subjects the adjunctive hemodynamic indicator with decision point -- a device that monitors medical conditions relating to blood flow -- to special regulatory controls, including mandating a risk assessment and the reporting of clinical data proving the devices's efficacy.
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) issued by the FDA with mandatory compliance requirements and enforcement mechanisms.
This document primarily addresses AI system safety, failures, and limitations (domain 7), with strong focus on lack of robustness (7.3) and lack of transparency (7.4). It also touches on privacy and security concerns (domain 2) through data quality requirements, and human-computer interaction risks (domain 5) through usability and overreliance mitigation.
This regulation exclusively governs the Health Care and Social Assistance sector, specifically medical device manufacturers and healthcare providers using AI-based hemodynamic monitoring devices. The regulation does not apply to other sectors.
The document comprehensively covers multiple AI lifecycle stages with particular emphasis on Verify and Validate, Deploy, and Operate and Monitor stages. It requires extensive validation testing, clinical data, and ongoing performance monitoring for hemodynamic indicator devices.
The document explicitly addresses AI systems (hemodynamic indicator devices) and algorithms but does not use terminology like 'AI models', 'frontier AI', 'GPAI', or 'foundation models'. It focuses on task-specific predictive AI for medical monitoring without mentioning compute thresholds or open-source models.
Food and Drug Administration (FDA)
This regulation is part of Title 21 of the Code of Federal Regulations, which is administered by the FDA. The FDA has statutory authority to regulate medical devices under the Federal Food, Drug, and Cosmetic Act.
Food and Drug Administration (FDA)
The FDA has enforcement authority over medical devices classified under 21 CFR. The agency conducts pre-market reviews, inspections, and can take enforcement actions for non-compliance with device regulations.
Food and Drug Administration (FDA)
The FDA monitors compliance with medical device regulations through pre-market submissions, post-market surveillance, and inspection programs. The special controls require ongoing validation and clinical data that would be subject to FDA review.
Manufacturers of adjunctive hemodynamic indicator devices with decision points
The regulation applies to entities that develop and manufacture medical devices that monitor hemodynamic conditions. These entities must comply with the special controls outlined, including software validation, clinical data requirements, and labeling specifications.
8 subdomains (4 Good, 4 Minimal)