Radiological Imaging Devices

The US Food and Drug Administration (FDA) on Monday announced a proposal to down-classify certain medical image analyzers from class III to class II.

The proposed reclassification is part of ongoing efforts at FDA to strike an improved balance between pre- and postmarket data.

Computer-assisted/aided (CADe) detection devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules and radiograph dental caries detection—assigned product code MYN—would be impacted under FDA’s Center for Devices and Radiological Health (CDRH) proposed order.

“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,” CDRH wrote in the proposed order, first issued Friday.

Device down-classifications are aimed at reducing regulatory burden and the associated costs because the shift allows firms to move away from the more stringent premarket approval application (PMA) pathway toward the that of premarket notification—which requires a 510(k) submission to FDA.

“A 510(k) is a less-burdensome pathway to market a device which typically results in a more timely premarket review compared to a PMA and reduces the regulatory burden on industry in addition to providing more timely access of these types of devices to patients,” CDRH said.

The order also proposes the creation of a new classification regulation for CADe devices. Under the new regulation, these will be considered prescription devices, subject to prescription labeling requirements.

The suitability of the reclassification stems from the agency’s current understanding on reviews and analyses of related data, including only three recalls—none of which were class I—and just one medical device report (MDR), beginning from when the first device for the purposes described received premarket approval in 26 June 1998. This led to the conclusion that the safety profiles for CADe devices already regulated as class II, such as chest x-ray computer aided detection resemble those of class III.

A panel on radiological devices was convened by FDA to discuss how these devices are used to support clinical-decision making in 2008 and 2009 for the purposes of the proposed reclassification. These discussions were taken into consideration in determining the appropriate special and general controls to mitigate the known risks to patient health, such as false positive and false negative results.

Design verification and validation with detailed descriptions of image analysis algorithms, as well as detailed device labeling requirements are among the controls identified. FDA added it does not intend to exempt these devices from premarket notification, following the reclassification.