CDRH Industry: FDA Issues Final Order, "Reclassification of Iontophoresis Devices Intended for Any Other Purposes.”

On July 26, 2016, the FDA issued a final order “Reclassification of Iontophoresis Device Intended for Any Other Purposes.”   These are prescription devices that use an electrical current to introduce ions of drugs or non-drug solutions into the body for medical purposes.   Iontophoresis devices for any other purposes are not used in diagnosis of cystic fibrosis, or with a specific drug that is not specified in the labeling of the device. 

Under the final order, iontophoresis devices for any other purposes (product code EGJ) are reclassified from class III, preamendment devices, to class II with special controls.   FDA has concluded that special controls, in conjunction with general controls, will provide reasonable assurance of the safety and effectiveness of these devices.  Also this final order amends the device identification to clarify that devices intended to deliver specific drugs (product code KTB) are not considered part of this regulatory classification.  Under the new classification, manufacturers will need to submit a new 510(k) for an iontophoresis device regulated under product code EGJ if it is not currently on the market, or a marketed device is about to be significantly changed or modified. Manufacturers with devices currently on the market must comply with the special controls outlined in the final order.   

The FDA is issuing this final order as part of the 515 Program to ensure the appropriate regulation of Class III pre-amendments devices.

The order can be also be found by searching for docket number FDA-2016-614 on www.regulations.gov.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health