Federal Register :: Public Inspection: Radiology Devices: Reclassification of Medical Image Analyzers

Federal Register :: Public Inspection: Radiology Devices: Reclassification of Medical Image Analyzers

The FDA Reclassifies Medical Image Analyzers, Including Computer-Assisted Detection (CADe) Devices

Today, the U.S Food and Drug Administration (FDA) issued a final order to reclassify certain radiological medical image analyzers, including computer-assisted detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices, from Class III devices to Class II devices.  This final order:  Reclassifies certain CADe devices from Class III to Class II devices, subject to premarket notification (510(k)).  Provides special controls that in addition to general controls, will provide a reasonable assurance of safety and effectiveness for CADe devices. Streamlines review for these types of computer-assisted detection devices and provides more timely access to these devices for patients.

Read the Final Order The FDA has also updated the guidance Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions to make it consistent with this reclassification. Questions? If you have questions, contact the Division of Industry and Consumer Education.