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

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices.

The notice was published in the Federal Register on Dec. 29 by Lowell M. Zeta, Acting Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting partial exemption from the premarket notification requirements for radiology computer-aided detection and/or diagnosis devices and computer-aided triage and notification devices. Specifically, the petition requests exemption fr...