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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 and re-issued it on August 18, 2025, 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. On August 18, 2026 the FDA also published a discussion paper on regulating generative AI-enabled devices, with comments due by October 19, 2026 under docket FDA-2026-N-7874; the paper is not draft or final guidance. The FDA says it had authorized over 1,600 AI-enabled devices as of September 2026.
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.