FDA’s List of Artificial Intelligence-Enabled Medical Devices — what it is and is not

FDA’s List of Artificial Intelligence-Enabled Medical Devices describes itself as a resource intended to identify AI-enabled medical devices that are authorized for marketing in the United States. The page also states that the list is not a comprehensive resource of AI-enabled medical devices, and that it will continue to be updated periodically.

The guidance documents are separate. The PCCP guidance covers marketing-submission recommendations for planned modifications. The January 2025 lifecycle and marketing-submission document is labeled draft and not for implementation.

Editorial judgment: A device’s presence on the list is evidence that FDA authorized it for marketing; absence is not evidence of anything, because the page says the list is not comprehensive. Neither presence nor absence tells a buyer how the manufacturer verifies, monitors or changes the AI software. Those questions belong in vendor due diligence, not in a list lookup.