The Food and Drug Administration (FDA) issued a proposed rule to reclassify medical image analyzers applied to the detection of mammography breast cancer, ultrasound breast lesions, radiography lung nodules, and radiograph dental caries. These analyzers, currently classified as class III devices under section 513 of the FD&C Act (21 U.S.C. 360c), would be reclassified to class II devices loosening requirements for premarket approval to requiring premarket notification to the FDA (requirements for each are outlined in section 513(i) (21 U.S.C. 360c(i)) and section 510(k) (21 U.S.C. 360(k)) from the Food, Drug, and Cosmetic Act, respectively). If finalized, the FDA also proposes that these newly classified devices would be identified as prescription devices to be used and labeled according to prescription labeling requirements.
With these proposed changes, the FDA also seeks to introduce new means of regulatory control to ensure the safety and effectiveness of these devices that further elucidates these devices’ identification as a prescription device. Specifically, premarket notifications for these newly classified devices must include detailed descriptions of the devices' algorithms, datasets, and testing methodology to ensure design verification and validation. Notifications must also include performance testing of the devices indicating reduced risk of false positives and negative test results. Finally, device labeling must include detailed descriptions of who the device is intended for, risk mitigation strategies to ensure the device’s datasets are representative of the intended patient population, descriptions of how the device should be properly used, and what limitations and/precautions must be considered when using the device.