Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes
Information
Type
Rule
Regulated products
Published
July 26, 2016
Last updated
July 26, 2016
Description
Document number 2016-17609. The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)