Defines testing, performance, and disclosure requirements for devices that use advanced algorithms to help detect gastrointestinal lesions.
Analysis summaries, actor details, and coverage mappings were LLM-classified and may contain errors.
This is a binding federal regulation issued by the FDA under statutory authority (21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371) establishing mandatory requirements for medical device classification and special controls with legal enforceability.
This document has minimal coverage of AI risk domains, primarily addressing system safety and reliability (7.3) through performance testing requirements. It touches on human-computer interaction risks (5.1) through overreliance warnings and transparency requirements (7.4) through labeling mandates. The focus is narrow, addressing technical performance and safe use of a specific medical device rather than broader AI governance concerns.
This regulation primarily governs the Health Care and Social Assistance sector, specifically medical devices used in clinical settings for gastrointestinal diagnosis. It also has secondary relevance to the Scientific Research and Development Services sector through its requirements for clinical and non-clinical performance testing.
The document covers multiple AI lifecycle stages with primary focus on Verify and Validate, Deploy, and Operate and Monitor stages. It establishes comprehensive testing, validation, and performance requirements throughout the device lifecycle, from pre-market validation through post-market monitoring of adverse events.
The document explicitly addresses AI systems (computer-assisted detection device with advanced software algorithms) and focuses on task-specific/narrow AI for gastrointestinal lesion detection. It does not mention frontier AI, general purpose AI, foundation models, or compute thresholds.
Food and Drug Administration (FDA); Lauren K. Roth, Associate Commissioner for Policy
The document is a federal regulation issued by the FDA under its statutory authority. It is signed by Lauren K. Roth as Associate Commissioner for Policy, indicating FDA authorship and proposal.
Food and Drug Administration (FDA)
The FDA has enforcement authority over medical devices under Title 21 U.S.C. and enforces compliance with the special controls established in this regulation through its pre-market review and post-market surveillance processes.
Food and Drug Administration (FDA)
The FDA monitors compliance through requirements for clinical performance testing, adverse event evaluation, and ongoing device performance assessment as specified in the special controls.
Manufacturers of gastrointestinal lesion software detection systems
The regulation applies to entities that develop and market gastrointestinal lesion software detection systems, which are computer-assisted detection devices using advanced software algorithms. These entities must comply with the special controls for Class II medical devices.
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