FDA Shoots Down Bid for Review Exemption on Company’s Radiology AI Devices, Citing Safety Gaps
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April 17, 2026
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The FDA denied Harrison.ai's request to bypass premarket review for radiology AI devices, emphasizing the need for safety validation.
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Harrison.ai sought exemption for various AI tools, including CADx software, arguing that prior 510(k) clearance should allow future bypass.
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The FDA criticized the proposal's reliance on manufacturer self-monitoring, highlighting the lack of independent evaluation mechanisms.
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Feedback on the proposal was largely negative, with concerns about patient safety and the immaturity of postmarket AI monitoring.
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The FDA suggested Predetermined Change Control Plans as a compromise, allowing pre-approval for future AI updates after initial review.
