Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease
Key claim: FDA is placing software that flags fibrotic lung disease findings on radiology images into class II with special controls, so makers can generally clear these tools through the 510(k) pathway instead of a stricter premarket process.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
Routine Class II classification of radiology software expands the growing roster of FDA-cleared imaging AI tools that can reach the market via 510(k) rather than premarket approval. For patients and providers, it signals a lower regulatory barrier for software that flags suspected fibrotic lung disease on radiology images, while special controls set baseline performance and labeling expectations.