FDA Issues Proposed Order to Down-Classify Certain Radiological Medical Image Analyzers

The U.S. Food and Drug Administration is issuing a proposed order to reclassify certain radiological medical image analyzers, which include computer-assisted detection devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices, from class III to class II devices.

If finalized, this proposed order will reclassify computer-assisted detection 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 computer-assisted detection devices, and provide more timely access to these devices for patients.

The FDA is proposing special controls which, 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 through a more consistent and streamlined approach to review many types of radiological computer assisted-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 FDA welcomes comments regarding this proposed order. The comment period will be open for 60 days.

If you have any questions about this proposed order, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100.