Federal Register #2026-22180

FDA Classifies Fibrotic Lung Disease Radiology Software as a Class II Device

The FDA issued a final order establishing Class II controls for software that analyzes CT images for fibrotic lung disease findings. - Government buyer: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). - Opportunity status: This is a regulatory classification, not a procurement solicitation or award; no purchase is announced. - Device and intended use: Prescription radiology image-processing software analyzes computed tomography (CT) images and provides adjunctive information to support referral related to fibrotic lung disease. It is used as part of a broader diagnostic assessment. - OEMs and vendors: None identified. - Notable requirements: Special controls include clinical performance validation; postmarket surveillance when required by FDA; software verification, validation, and hazard analysis; and labeling covering compatible imaging equipment and protocols, performance, limitations, and appropriate use with other clinical and diagnostic findings. - Products, quantities, and part numbers: No specific commercial product, quantity, or part number is identified.

Description

The FDA is classifying radiology software for referral of findings related to fibrotic lung disease as a Class II medical device subject to special controls. The prescription image-processing device analyzes computed tomography images and provides adjunctive information for use in a referral pathway as part of diagnostic assessment. The order establishes special controls covering clinical performance validation and postmarket surveillance, software verification and validation, hazard analysis, and labeling. The classification became applicable January 12, 2024, and the final order is effective October 30, 2026.

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