Federal Register #2026-12166

FDA Classifies Radiological Machine Learning-Based Quantitative Imaging Software as Class II Medical Device

This opportunity involves a regulatory classification by the Food and Drug Administration (FDA) for a specific type of medical software: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Scope: - Classification of radiological machine learning-based quantitative imaging software as a Class II medical device - Applies to software-only devices using machine learning algorithms on radiological images to provide quantitative outputs (e.g., view selection, segmentation, landmarking) - Requirements: - Devices must include a predetermined change control plan - Special controls for design verification, validation, risk management, and labeling - Ensures safety and effectiveness while reducing regulatory burdens for future devices - No procurement action: - No OEMs, vendors, part numbers, or purchase quantities are specified - This is a regulatory notice, not a solicitation or award

Description

The Food and Drug Administration (FDA) is classifying the radiological machine learning-based quantitative imaging software with predetermined change control plan into class II with special controls. This classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens. The device is software-only, employing machine learning algorithms on radiological images to provide quantitative imaging outputs, including functions such as view selection, segmentation, and landmarking. The order is effective from June 17, 2026, and has been applicable since February 24, 2023.

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