Zdrowie i gospodarka · 22/09/2014

FDA Proposes to Reclassify Iontophoresis Devices for Expanded Uses

The Food and Drug Administration (FDA) is proposing to reclassify iontophoresis devices intended for purposes beyond their original intent, from a preamendments class III device to a class II device with special controls, and to update the device identification, based on new information and in accordance with statutory requirements.