Artificial Intelligence and Machine Learning in Software as a Medical Device

By U.S. Food and Drug Administration.

Summary: FDA’s official regulatory framework for AI/ML-enabled diagnostic and clinical software.

Relevance: In the Health & Care subdomain: the FDA’s own regulatory framework for AI/ML-enabled diagnostic and clinical software, useful for social workers in healthcare settings who need to understand how loosely clinical AI tools are actually vetted before reaching patients.

Key findings: FDA acknowledges its “traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies,” and has built out guidance piecemeal since a 2021 Action Plan, including 2023 Predetermined Change Control Plan principles letting manufacturers modify already-authorized AI/ML devices within preset parameters without new premarket review, and 2024 transparency principles for ML-enabled devices.

Read the original: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-software-medical-device