The FDA has denied a petition seeking to exempt certain radiology AI devices from premarket review requirements.
The request, submitted Oct. 22, 2025, sought partial exemption from 510(k) requirements for computer-aided detection and diagnosis devices and triage and notification software. The FDA published the petition Dec. 29 and received more than 45 comments before the Feb. 27 deadline.
The agency said premarket notification remains necessary to ensure safety and effectiveness, citing concerns about device performance variability, risk of false results and limitations of postmarket monitoring, according to an April 1 letter.
The FDA also said prior 510(k) clearances for similar devices do not eliminate the need to review new products and rejected proposals to rely on manufacturer-led postmarket plans instead of premarket oversight.
The agency said it will continue exploring regulatory approaches for AI-enabled devices, including predetermined change control plans to support modifications while maintaining safety standards.
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