The U.S. Food and Drug Administration (FDA) has issued a final order requiring that a premarket approval (PMA) application be filed for a breast imaging technology called breast transillumination.
Such devices are categorized as class III medical devices, which require PMA applications with supporting data from clinical trials. Most medical imaging devices are considered class II devices, which usually are cleared via the 510(k) process, according to the FDA.
In 2012, in response to a petition by PWB Health to reclassify its breast transillumination system as a class II device, the FDA's device classification panel met and determined that there was not enough evidence to ensure the device's safety and effectiveness for the diagnosis of cancer and other conditions, diseases, or abnormalities. The panel concluded that the device should remain in class III.
Since then, the FDA has not received any information that would support a different classification. The final order was published in the Federal Register on January 17.
