FDA Reclassifies Certain Medical Image Analyzers

Posted January 28, 2020

The Food and Drug Administration (FDA) has issued final guidance reclassifying—from Class III to Class II—medical image analyzers under product code MYN, including computer-assisted detection (CADe) devices used for ultrasound breast lesions, mammography/breast cancer, and radiographic detection of lung nodules and dental cavities.

With the reclassification to Class II, the FDA identified special controls that it deems necessary to reasonably assure the safety and effectiveness of the devices. The order goes into effect on Feb. 21, 2020. The final rule means that rather than submitting a premarket approval application (PMA), manufacturers will be required to submit a less strenuous premarket notification 510(k) for these device types.

The guidance, which is titled Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data—Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions, applies to CADe devices classified under 21 CFR 892.2050 (“Picture archiving and communications systems”) and those under 21 CFR 892.2070 (“Medical image analyzer”), including the product codes NWE (colon computed tomography system, computer-aided detection),·OEB (lung computed tomography system, computer-aided detection), and·MYN (medical image analyzer).

CADe devices are intended to direct the attention of clinicians to “portions of an image, or aspects of radiology device data, that may reveal abnormalities,” according to the FDA. Examples of radiological data include images resulting from ultrasound, radiography, computed tomography, magnetic resonance imaging, and positron emission tomography.

The agency had proposed reclassifying the devices from Class III to Class II in June 2018, stating that evidence indicated that the safety profiles for existing Class III CADe devices were similar to other CADe devices that had been regulated as Class II.