FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; RADIOLOGY DEVICES; CLASSIFICATION OF THE RADIOLOGY SOFTWARE FOR REFERRAL OF FINDINGS RELATED TO FIBROTIC LUNG DISEASE

WASHINGTON, Oct. 30 -- Food and Drug Administration has issued a rule called: Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease.

The rule was published in the Federal Register on Oct. 30 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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 fib...