FDA AI/ML Medical Device Framework
In effect since
Overview
FDA requires pre-market review (510(k), De Novo, PMA) for AI/ML-based software that meets the definition of a medical device. Over 1,000 AI/ML-enabled devices authorized as of 2025. Includes predetermined change control plan for adaptive AI/ML devices. Most mature federal AI regulatory framework. Sector-specific. Has been operating for years.
This is federal agency guidance interpreting existing statutes and rules.
Who this applies to
This regulation applies to both companies that build AI products and companies that use AI tools from other vendors.
AI categories covered
- Healthcare AI
Specific AI use cases:
- Diagnostic and clinical AI
- Insurance prior authorization
What this requires you to do
Risk management program required
Implement a risk management program. Maintain ongoing processes to identify, assess, and mitigate AI-related risks.
Impact assessment required
Complete an impact assessment. Document the potential risks and effects of your AI system on affected people.
Record-keeping required
Maintain records. Keep documentation of your AI systems, decisions made, and compliance activities.
Enforcement and penalties
FDA enforcement actions including product recalls, warning letters, and injunctions.
Legislative history
How this law got here
Latest
effectivePredetermined change control and AI/ML device policies in active use
Earliest
Source
Read the full text
Last verified: April 9, 2026
Always verify current language and amendments at the official source.
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