The FDA today imposed stricter regulations on certain radiological medical image analyzers, reclassifying them from Class III to Class II.
Affected products include computer-assisted detection (CADe) devices for breast cancer mammography, breast-lesion ultrasound, and lung-nodule and dental-caries radiography, the agency said. It defines these devices as those intended to identify, mark, highlight, or in any other manner direct the clinicians’ attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians.
The devices incorporate pattern-recognition and data-analysis capabilities and operate on previously acquired medical images. They are not intended to replace the review by a qualified radiologist or intended to be used for triage or to recommend diagnosis.
The reclassification means that these devices are now subject to premarket notification (510(k)) regulation and special controls that the agency said “will provide a reasonable assurance of safety and effectiveness for CADe devices.” The order also streamlines review for these types of computer-assisted detection devices and provides more timely access to these devices for patients, the FDA said.
There have been no adverse event reports related to these CADe devices in the past 10 years, the agency added. An unpublished version of the reclassification order may be found here. Publication is expected on Wednesday.
The FDA said it 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.