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FDA Artificial Intelligence/Machine Learning-Based Software as a Medical Device Action Plan

United States (Federal) | FDA AI/ML Action Plan (2021)

Year Enacted
2021
Date Signed
Jan 12, 2021
Effective Date
Jan 12, 2021
Status
Enacted
Published January 12, 2021; non-binding strategic plan driving subsequent regulatory actions

Categories

Provider Clinical Use

Key Requirements

Commits FDA to a total product lifecycle (TPLC) approach for AI/ML devices. Five action areas: (1) PCCP guidance, (2) AI device labeling and transparency, (3) regulatory science for ML evaluation and bias identification, (4) real-world performance monitoring, and (5) Good Machine Learning Practices (GMLP) development.

Regulated Parties

AI/ML medical device manufacturers; Software as a Medical Device (SaMD) developers

Enforcement

FDA (Center for Devices and Radiological Health; Digital Health Center of Excellence)

Sources

Official https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-aiml-software-medical-device

Notes

Strategic framework that spawned subsequent binding guidance including GMLP Guiding Principles (Oct 2021), PCCP Draft Guidance (Apr 2023), and PCCP Final Guidance (Dec 2024). By 2025, FDA had authorized over 1,000 AI-enabled devices.

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