When does the FDA AI/ML SaMD Guidance take effect?

The FDA Action Plan for AI/ML-Based Software as a Medical Device took effect on January 13, 2021.

FDA AI/ML SaMD Guidance: What Small Teams Need to Know

FDA Action Plan for AI/ML-Based Software as a Medical Device

Dates and status re-checked against primary sources on September 30, 2026. How we verify

The FDA regulates AI and machine learning software that meets the definition of a medical device (Software as a Medical Device, or SaMD). Its January 2021 AI/ML action plan led to guidance on pre-market review and on predetermined change control plans (PCCPs). The FDA finalized its PCCP guidance for AI-enabled device software functions on December 4, 2024, letting manufacturers pre-authorize planned modifications as part of a 510(k), De Novo or PMA submission instead of filing a new one for each change.

What this means for your team

If you build or sell software that analyzes medical images, assists clinical diagnosis, monitors patient vitals, or supports treatment decisions, and your software influences the diagnosis or treatment of disease, it may be a medical device subject to FDA regulation. This includes AI tools embedded in electronic health records, telehealth platforms, or wearable devices that make clinical recommendations. Whether you need FDA review, and through which pathway, depends on the device's classification and intended use. A PCCP can spare you a new submission for each planned model update.

Key requirements

AI/ML SaMD may need 510(k) clearance, De Novo authorization or PMA before US marketing, depending on risk

Predetermined Change Control Plan (final guidance December 4, 2024): pre-authorize planned modifications within the initial marketing submission

Describe the planned modifications, how they will be validated, and their impact in the PCCP

Plan for post-market monitoring of real-world performance

Good Machine Learning Practice (GMLP) principles apply to development and validation

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FDA Action Plan for AI/ML-Based Software as a Medical Device

Dates and status re-checked against primary sources on September 30, 2026. How we verify

What this means for your team

Key requirements

AI/ML SaMD may need 510(k) clearance, De Novo authorization or PMA before US marketing, depending on risk

Predetermined Change Control Plan (final guidance December 4, 2024): pre-authorize planned modifications within the initial marketing submission

Describe the planned modifications, how they will be validated, and their impact in the PCCP

Plan for post-market monitoring of real-world performance

Good Machine Learning Practice (GMLP) principles apply to development and validation

FDA Action Plan for AI/ML-Based Software as a Medical Device

What this means for your team

Key requirements

Key terms

Further reading

FDA Action Plan for AI/ML-Based Software as a Medical Device

What this means for your team

Key requirements

Key terms

Further reading