FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; RADIOLOGY DEVICES; CLASSIFICATION OF THE RADIOLOGICAL COMPUTER-ASSISTED DETECTION AND DIAGNOSIS SOFTWARE

WASHINGTON, June 13 -- Food and Drug Administration has issued a rule called: Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Detection and Diagnosis Software.

The rule was published in the Federal Register on June 13 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA, the Agency, or we) is classifying the radiological computer-assisted detection and diagnosis software 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 the radiological computer-assisted detection and diagnosis software's classification. W...