FDA published an order on September 17 denying a petition that would have exempted four categories of radiology AI software from premarket notification. Nancy Stade of Rubrum Advising filed it on October 22, 2025 for Harrison.ai, the Sydney company behind the Annalise imaging tools. FDA denied the petition on April 1 and docketed the response as FDA-2025-P-5560.
The request reached across most of the radiology AI market: radiological computer-assisted diagnostic software (product code POK, 21 CFR 892.2060), medical image analyzers (MYN, 892.2070), computer-aided triage and notification software (QAS and QFM, 892.2080), and computer-assisted detection and diagnosis software (QBS and QDQ, 892.2090).
Harrison.ai did not ask for a blanket exemption. The proposal was conditional, open only to manufacturers that already held a clearance for the device type, ran postmarket surveillance and user training, and kept their quality system obligations. FDA weighed it against the four statutory exemption factors and wrote that the petition does not demonstrate that premarket notification is not necessary to assure safety and effectiveness.
For anyone shipping model updates on a schedule, this settles the near-term question. Every new indication and every new product code in that group still needs a submission and the review clock attached to it, so the predetermined change control plan remains the only lever that shortens the cycle.