Federal Register #FDA-2025-P-5560

FDA Denial of Exemption from Premarket Notification for Radiology Computer-Aided Devices

This notice addresses a regulatory decision by the Food and Drug Administration (FDA) regarding radiology computer-aided devices: - Government buyer: Food and Drug Administration (FDA), Department of Health and Human Services - Petition submitted by Harrison.ai for partial exemption from premarket notification (510(k)) requirements - Device types referenced: - Radiological computer-assisted diagnostic software for lesions suspicious of cancer (21 CFR 892.2060, product code POK) - Medical image analyzers (21 CFR 892.2070, product code MYN) - Radiological computer-aided triage and notification software (21 CFR 892.2080, product codes QAS and QFM) - Radiological computer-assisted detection and diagnosis software (21 CFR 892.2090, product codes QBS and QDQ) - Petition proposed exemption for devices with prior 510(k) clearance and robust post-market plans - FDA reviewed the petition and public comments, ultimately denying the exemption - Manufacturers must continue submitting 510(k) notifications before marketing these devices - No procurement, solicitation, or award is associated with this notice - Only Harrison.ai is mentioned; no other OEMs or vendors are referenced - No products or services are being requested or procured

Description

The Food and Drug Administration (FDA) published a final order regarding a petition for partial exemption from premarket notification requirements for certain radiology computer-aided detection, diagnosis, triage, and notification devices. The petition requested exemption for specific generic device types under certain conditions, including prior 510(k) clearance and implementation of post-market plans. After review and public comment, FDA denied the petition, requiring manufacturers to continue submitting 510(k) notifications before marketing these devices. The order is effective September 17, 2026.

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