21 CFR § 876.1520 ("Gastrointestinal lesion software detection system")

• Authority: Food and Drug Administration
• Parent authority: Federal government
• Jurisdiction: United States
• Collections: U.S. regulations, executive orders, and agency policies
• Most recent activity: Enacted
• Most recent activity date: 2023-01-03

Risk subdomain coverage

Good coverage — Comprehensive governance measures or mitigations with clear procedures relating to the risk subdomain are explicitly described.

• Lack of capability or robustness

Minimal coverage — Brief mention but no specific mitigations, recommendations or governance measures relating to the risk subdomain are described.

• Overreliance and unsafe use
• Lack of transparency or interpretability

All other risk subdomains had no coverage in this document.

Risk Coverage Summary

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.

Sector coverage

Good coverage — Comprehensive governance measures or mitigations with clear procedures relating to the sector are explicitly described.

• Health Care & Social Assistance

Minimal coverage — Brief mention but no specific mitigations, recommendations or governance measures relating to the sector are described.

• Scientific Research & Development Services

All other sectors had no coverage in this document.

Sectors Summary

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.

Legislative Status

Hard Law

Legislative Status Summary

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.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA); Lauren K. Roth, Associate Commissioner for Policy
• Summary: 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.

Target

• Entity Types: AI_Developer, AI_Deployer
• Entities: Manufacturers of gastrointestinal lesion software detection systems
• Summary: 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.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: 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.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: The FDA monitors compliance through requirements for clinical performance testing, adverse event evaluation, and ongoing device performance assessment as specified in the special controls.

AI Lifecycle Stages

Lifecycle stages covered by the documents, as defined in the OECD Framework for the Classification of AI Systems

• Plan and Design
• Build and Use Model
• Verify and Validate
• Deploy
• Operate and Monitor

AI Lifecycle Summary

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.

Technical Scope

Terms relating to technical scope that are mentioned or implicitly referenced in the document

• AI Models
• AI Systems
• Predictive AI
• Task-specific AI

Technical Scope Summary

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.