FDA: Tightening AI & Select Approvals

A medical device can now be a box, a catheter, or just software that reads an image and tells a doctor what it sees. The Food and Drug Administration has been trying to answer the same question for all three: when does a new tool need fresh review before it reaches patients? (fda.gov) That question got sharper with artificial intelligence systems that can be updated like phone apps. In 2023, the Food and Drug Administration published draft guidance saying these devices need a full life-cycle plan that covers data quality, bias, transparency, and future changes, not just a one-time test at launch. (fda.gov) In August 2025, the agency finalized another piece of that approach: a “Predetermined Change Control Plan,” which is a pre-agreed rulebook that lets a company make certain software updates later without filing a brand-new application every time. The point was not “no regulation,” but “tell us in advance what you plan to change and how you will keep it safe.” (ballardspahr.com) Then one company asked for something looser. Harrison.ai filed a petition on October 22, 2025 asking the Food and Drug Administration to partially exempt some radiology image-analysis software from the usual premarket review if the company already had a cleared product in a similar category and followed technical standards with post-market monitoring. (statnews.com) The Food and Drug Administration opened that request for public comment in the Federal Register on December 29, 2025. The petition covered several Class II radiology software categories, including computer-aided detection, diagnosis, and triage tools that flag suspicious findings on scans. (federalregister.gov) On April 9, 2026, the agency said no. Trade coverage reported that the Food and Drug Administration denied the exemption request, which means those artificial intelligence radiology tools still cannot skip the 510(k) pathway, the review process used to show a new device is substantially equivalent to one already on the market. (beckershospitalreview.com) That decision did not come from an agency that has frozen device approvals. The Food and Drug Administration’s own artificial intelligence device list was updated last week and says it tracks authorized artificial intelligence-enabled devices that are already legally marketed in the United States. (fda.gov) The same selective pattern shows up outside software. In October 2024, the Food and Drug Administration granted an Investigational Device Exemption to iota Biosciences, an Astellas subsidiary, for an early feasibility study of an implant that delivers electrical stimulation to the bladder wall to help people with underactive bladder empty their bladder. (urologytimes.com) An Investigational Device Exemption is permission to test a device in people before it is cleared for sale, like getting approval to take a prototype onto a closed track before driving it on public roads. Astellas said the bladder study received staged approval and would begin as a first-in-human early feasibility trial. (newsroom.astellas.com) The portable dialysis example sits on the other side of that line. Fresenius Medical Care said on April 21, 2022 that the Food and Drug Administration granted 510(k) clearance to its Versi peritoneal dialysis cycler, which the company described as the smallest, lightest, and quietest automated peritoneal dialysis system in the United States. (freseniusmedicalcare.com) Put together, the message is narrower than “the agency is cracking down” and narrower than “the agency is getting out of the way.” The Food and Drug Administration is still clearing devices and green-lighting studies, but when companies ask to remove a layer of review for artificial intelligence tools that read scans, the agency is keeping that checkpoint in place. (fda.gov)