On October 30, 2026, the Food and Drug Administration (FDA) announced the classification of radiology software for referral of findings related to fibrotic lung disease into class II (special controls). This classification is intended to provide a reasonable assurance of the safety and effectiveness of the device, according to the FDA.
The classification takes effect on October 30, 2026, and was applicable as of January 12, 2024. For more details, see the Federal Register document.
Press Release: Food and Drug Administration
Published October 30, 2026. Reproduced in full from the Food and Drug Administration.
Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease
Action: Final amendment; final order.
Summary
The Food and Drug Administration (FDA) is classifying the radiology software for referral of findings related to fibrotic lung disease into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the radiology software for referral of findings related to fibrotic lung disease. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Key dates
- Takes effect: October 30, 2026
This order is effective October 30, 2026. The classification was applicable on January 12, 2024.
Full text: Federal Register document 2026-22180
