FDA classifies radiology software for fibrotic lung disease as class II
The FDA finalized an order classifying the radiology software for referral of findings related to fibrotic lung disease as class II with special controls that will be part of the codified language for classification. The agency said the classification provides reasonable assurance of safety and effectiveness and may enhance patients' access to beneficial innovative devices by reducing regulatory burdens.
Primary source
Federal Register rule, October 30, 2026
Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease
Read the source: Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease federalregister.gov
Machine-summarized from the source above; not independently reported. How we use automation