The US Food and Drug Administration (FDA) has issued a final order to reclassify select radiological medical image analysers, including computer-assisted detection (CADe) devices, from class III to class II devices.
The order will be effective from 21 February 2020. The reclassification will be subject to 501(k) premarket notification.
Alongside the reclassification, the FDA will set special controls to provide a reasonable assurance of safety and effectiveness for CADe devices. The review of these devices will also be streamlined to provide more timely access for patients.
Analysers included in the reclassification are those applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules and radiograph dental caries detection.
The devices are all intended to direct a clinician’s attention to portions of an image that could reveal abnormalities while interpreting a patient’s scans. They incorporate pattern recognition and data analysis capabilities and operate based on historical medical images, but are not intended to replace the review of a qualified radiologist, to be used for triage or to recommend a final diagnosis.
The three classes of devices are are: low-risk class I devices subject to general controls, medium-risk class II devices subject to special conditions like 501(k) premarket notification and high-risk class III devices requiring a premarket approval (PMA) order.
A 501(k) allows a device to enter the market if it can be established as being substantially equivalent to another FDA pre-approved device. Applying for a PMA is a longer process for devices which are completely new to the market or categorised as class III, and requires extensive clinical evidence such as laboratory and trial data before it can enter the market.
The FDA has now concluded that special controls like 501(k) will provide a reasonable assurance of the safety and effectiveness of these select medical image analysers, and that PMA is no longer necessary.
Manufacturers of these select medical imaging devices will still need to undergo 501(k) premarket notification processes.
The FDA’s final report on the matter reads: “FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of medical image analysers, and therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market a new CADe device must obtain clearance of a premarket notification and demonstrate compliance with the special controls included in this final order, prior to marketing the device.”