21 CFR § 864.3750 ("Software algorithm device to assist users in digital pathology")

• 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: 2023-02-02

Risk subdomain coverage

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

• Unequal performance across groups
• AI system security vulnerabilities
• Lack of capability or robustness
• Lack of transparency or interpretability

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

• Unfair discrimination and misrepresentation
• Overreliance and unsafe use

All other risk subdomains had no coverage in this document.

Risk Coverage Summary

The document has good coverage of approximately 5-6 subdomains, with strong focus on AI system security (2.2), lack of capability or robustness (7.3), lack of transparency or interpretability (7.4), and competitive dynamics (6.4). Coverage is concentrated in system safety, security, and technical performance domains.

Sector coverage

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

• Health Care & Social Assistance

All other sectors had no coverage in this document.

Sectors Summary

The document exclusively governs AI use in the Health Care and Social Assistance sector, specifically focusing on diagnostic medical devices for digital pathology. It establishes comprehensive regulatory requirements for software algorithms used in pathology diagnosis.

Legislative Status

Hard Law

Legislative Status Summary

This is a binding federal regulation from the FDA with mandatory requirements and enforcement mechanisms. The regulation uses mandatory language throughout ('must') and establishes special controls that are legally enforceable requirements for Class II medical devices.

Actors

Proposer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: The document is a federal regulation issued by the FDA under Title 21 of the Code of Federal Regulations, establishing special controls for software algorithm devices in digital pathology.

Target

• Entity Types: AI_Developer, AI_Deployer
• Entities: Manufacturers and deployers of software algorithm devices for digital pathology
• Summary: The regulation applies to entities that develop, manufacture, and deploy software algorithm devices intended to assist users in digital pathology diagnosis. These are Class II medical devices subject to special controls.

Enforcer

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: The FDA has authority to enforce compliance with these special controls, including determining acceptable performance standards and ensuring regulatory compliance for Class II medical devices.

Monitor

• Entity Types: AI_Governance_Actor
• Entities: Food and Drug Administration (FDA)
• Summary: The FDA monitors compliance through review of device performance data, validation studies, and ongoing oversight of Class II medical devices under its regulatory authority.

AI Lifecycle Stages

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

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

AI Lifecycle Summary

The document comprehensively covers multiple AI lifecycle stages with primary focus on Build and Use Model, Verify and Validate, Deploy, and Operate and Monitor stages. It provides detailed requirements for software development, training data, validation testing, labeling, and ongoing risk management.

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 covers AI systems and software algorithms for digital pathology. It focuses on task-specific AI for medical diagnosis assistance. There is no mention of frontier AI, general purpose AI, foundation models, generative AI, or compute thresholds. The document addresses predictive AI in the context of diagnostic assistance.