FOOD AND DRUG ADMINISTRATION ISSUES RULE: MEDICAL DEVICES; EXEMPTION FROM PREMARKET NOTIFICATION: RADIOLOGY COMPUTER-AIDED DETECTION AND/OR DIAGNOSIS DEVICES AND COMPUTER-AIDED TRIAGE AND NOTIFICATION DEVICES

WASHINGTON, Sept. 17 -- Food and Drug Administration has issued a rule called: Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices.

The rule was published in the Federal Register on Sept. 17 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA) is publishing an order setting forth its final determination regarding a partial exemption from the premarket notification requirements for radiology computer-aided detection and/or diagnosis devices and computer-aided triage and notification devices that was the subject of a notice published in the F...