The US Food and Drug Administration (FDA) is seeking public comment on a 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. 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.
This proposed order applies to medical image analyzers including computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection that are currently regulated as class III devices as postamendment devices. These devices are 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. These devices incorporate pattern recognition and data analysis capabilities and operate on previously acquired radiology images, including mammography, radiograph, and ultrasound. These devices are not intended to replace the review by a qualified radiologist or to be used for triage. Furthermore, these devices are not intended to recommend diagnosis of any diseases.