Medical Devices; Exemption From Premarket Notification: Radiology Computer-Aided Detection and/or Diagnosis Devices and Computer-Aided Triage and Notification Devices

摘要

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 from the premarket notification requirements for the following generic device types when certain conditions described in the petition are met: radiological computer-assisted diagnostic software for lesions suspicious of cancer; medical image analyzers; radiological computer aided triage and notification software; and radiological computer- assisted detection and diagnosis software. FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).