Radiology Devices; Reclassification of Medical Image Analyzers

The Food and Drug Administration (FDA or the Agency) is issuing this proposed order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection as postamendments class III (premarket approval) devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. These devices are intended to direct the clinician's attention to portions of an image that may reveal abnormalities during interpretation of patient's radiology images by the clinician. If finalized, this order will reclassify these types of devices from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.