The Food and Drug Administration (FDA) has issued a proposed order to reclassify certain radiological medical image analyzers, including computer-assisted detection devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules and radiograph dental caries detection devices, from class III to class II devices.
If finalized, reclassification would allow manufacturers of these devices to use a less burdensome process -- premarket notification (510(k) with special controls – in lieu of the current premarket approval regulatory process.
The FDA anticipates the proposed order will reduce the regulatory burden of bringing such devices to market, streamline its review process and provide more timely access to these devices for patients. It believes special controls, specified in the proposal, will complement the agency’s general controls to provide a reasonable assurance of safety and effectiveness.
The proposed order describes several ways to file comments with the FDA about the plan. The comment period will end August 3, 2018.