Intracorporeal lithotripters
This article was originally published in The Gray Sheet
Executive Summary
Preamendments Class III device (21 CFR 876.4480) is among the products proposed for Class II status as part of a mass reclassification effort by FDA, staffers say. A proposed rule listing the 38 preamendments, Class III devices to be downclassified is expected in January. A guidance document for intracorporeal lithotripters released on the FDA website Nov. 30 will serve as the special control for the device following its placement into Class II. The guidance codifies what FDA has previously required for 510(k)s for lithotripters