Medical isotope producer Advanced Medical Isotope (AMIC) has filed a de novo submission with the U.S. Food and Drug Administration (FDA) for its yttrium-90 (Y-90) RadioGel brachytherapy cancer device.
The application requests that the FDA reclassify the device as a class II product and allow AMIC to market it commercially. The device combines insoluble Y-90 microspheres and a polymer carrier that is injected directly into a tumor.
In February, the FDA rejected AMIC's request for 510(k) marketing clearance for the same device. According to the company, the FDA ruled the device was not substantially equivalent, classifying it as a class III medical device.
AMIC noted that if the de novo submission is granted, the device may be immediately marketed in the U.S., but the company will need to secure funding and commercial arrangements prior to the launch. If the de novo submission is declined, AMIC may seek approval for the device as a class III medical device.
