June 1, 2018 — The U.S. Food and Drug Administration (FDA) is issuing a proposed order to reclassify certain radiological medical image analyzers, or computer-aided detection (CAD) devices, from class III to class II devices. This includes CAD devices for mammography breast cancer, ultrasound breast lesions and radiograph lung nodules.
If finalized, this proposed order will reclassify CAD devices for certain radiological applications from Class III devices requiring premarket approval, to Class II devices, requiring a less burdensome premarket notification (510(k)) with special controls. This will reduce the regulatory burden on the medical device industry, streamline review for these types of devices, and provide more timely access to these devices for patients.
The agency is proposing special controls that, in addition to general controls, will provide a reasonable assurance of safety and effectiveness.
This proposed order is part of the Center for Devices and Radiological Health’s goal to strike the right balance between premarket and postmarket data collection. This proposed order also promotes innovation in diagnostic imaging, according to the FDA, through a more consistent and streamlined approach to review many types of radiological computer aided-detection, diagnosis and triage software under the 510(k) pathway. Streamlined premarket review will provide for more timely access to these types of devices for patients, while still maintaining the highest standards of safety and effectiveness.
The agency said it welcomes comments regarding this proposed order. The comment period will be open for 60 days.
Questions about this proposed order can be directed to CDRH’s Division of Industry and Consumer Education (DICE) at [email protected], or via phone at 1-800-638-2041, or (301) 796-7100.
For more information: www.fda.gov
December 03, 2025 
