FDA Proposes Reclassification of Computer-Aided Detection Devices

June 4, 2018

The agency has proposed an order to reclassify certain radiological medical image analyzers from class III to class II devices.

The order, which includes devices used to detect mammography breast cancer, radiograph lung nodules and ultrasound breast lesions, would reclassify devices requiring premarket approval to reduce burden on the medical device industry.

The proposition, which is intended to promote innovation in diagnostic imaging, also includes special controls that will provide a level of safety and effectiveness.

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