2026-22180·DEPARTMENT OF HEALTH AND HUMAN SERVICES

Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease

Final RuleEffective

Published: Oct 30, 2026
Effective: Oct 30, 2026
Citation: 91 FR 68467
Docket: Docket No. FDA-2026-N-12254
Agencies: DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Final amendment; final order.

Summary

The Food and Drug Administration (FDA) has re‑classified a specific type of radiology software that helps doctors refer findings related to fibrotic lung disease from a Class III (high‑risk) status to Class II, which is subject to “special controls.” By placing the software in the lower risk category, the agency believes it can still ensure safety and effectiveness while making it easier for manufacturers to bring innovative tools to market and for patients to access them. This final rule, issued by the U.S. Department of Health and Human Services’ FDA, applies to any company that designs, manufactures, or distributes the radiology referral software for fibrotic lung disease in the United States. Health‑care providers who use the software and patients whose care involves such tools are also indirectly affected, as the change could speed up availability of new or updated products. The rule was published in the Federal Register on October 30, 2026 (91 FR 68467) and became effective the same day. Because the amendment is final, there is no additional public comment period; manufacturers must now comply with the identified special controls when seeking FDA clearance for these devices. The FDA will incorporate the special controls into the official classification language, and companies can proceed with the revised, streamlined regulatory pathway for future submissions.

AI-generated summary — verify against the Federal Register text.

Official abstract

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.