New FDA proposal could streamline approval process for CAD software

The FDA has proposed reclassifying medical image analyzers used in mammography for breast cancer, ultrasound for breast lesions, x-ray for lung nodules and x-ray for dental caries as class II medical devices instead of class III. This proposal would make it easier for medical device manufacturers to gain FDA approval for computer-assisted detection devices that fall under those specific categories.

“If finalized, this order will reclassify these types of devices from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome premarket notification (510(k)) before marketing their device,” the FDA stated in the proposed order.

The proposal, which can be read in full here, will be published in the Federal Register on June 4. There will be a 60-day comment period. Electronic or written comments will be accepted and will be made public.