FDA previews AI rules

The Food and Drug Administration is preparing tighter rules for medical devices that use artificial intelligence, even as it keeps clearing new software-heavy products. (medtechdive.com) Michelle Tarver, who leads the FDA’s Center for Devices and Radiological Health, said on April 17 at the Association for the Advancement of Medical Instrumentation’s neXus conference that the agency plans final guidance on AI lifecycle management and “initial thoughts” on generative AI by the end of 2026. (medtechdive.com) The FDA’s January 6, 2025 draft guidance told device makers to show how AI systems are designed, tested, documented and monitored after launch, with specific attention to transparency, bias and performance drift over time. The agency said then that it had already authorized more than 1,000 AI-enabled devices through existing review pathways. (fda.gov 1) (fda.gov 2) That lifecycle approach treats an AI device less like a fixed tool and more like a product that can change after it reaches hospitals and patients. Tarver said the FDA wants developers to train algorithms on data that reflects the intended patient population and to validate them in that same population. (medtechdive.com) The agency is also building a separate playbook for generative AI, the category that can produce text, images or code. FDA’s Digital Health Advisory Committee first examined total product lifecycle issues for generative AI devices in November 2024 and then met again on November 6, 2025 on generative AI-enabled digital mental health devices. (fda.gov) (sidley.com) At the same time, the FDA has kept clearing novel devices that depend on software, sensors or connected hardware. In August 2025, the agency finalized guidance on predetermined change control plans, which let manufacturers spell out in advance what AI-related software changes they expect to make after a device is on the market. (fda.gov) One recent example is a newly cleared cardiogenic shock tool from Etiometry. The company said the FDA cleared its Cardiogenic Shock Tool in April 2026 under 510(k) number K254066 to automate hospital-specific shock classification and tracking from physiologic monitoring data aligned with Society for Cardiovascular Angiography and Interventions staging. (etiometry.com) (hospitals-management.com) Another is the Flow FL-100, an at-home depression device approved on December 8, 2025 through the premarket approval pathway. FDA documents say it delivers 2.0 milliamps of low-intensity direct current through scalp electrodes and is indicated for adults 18 and older with moderate to severe major depressive disorder in the current episode, either alone or alongside other treatment. (accessdata.fda.gov) A separate at-home depression device, ProlivRx, won FDA approval in January 2026 as a prescription, physician-directed adjunct for adults with major depressive disorder who did not get enough benefit from at least one antidepressant. Psychiatric Times reported that the device uses external stimulation aimed at occipital and trigeminal nerve pathways rather than drugs or in-clinic procedures. (psychiatrictimes.com) The FDA’s message is not that software-driven devices will slow down. It is that companies should expect more detailed evidence on how these systems behave before launch, after updates and in real-world use. (medtechdive.com) (fda.gov)