Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes
other · Food and Drug Administration · Rule · Published 2016-07-26 · Effective 2016-07-26 · 81 FR 48703
Document
Document number
2016-17609
Federal Register citation
81 FR 48703
CFR reference
21 CFR 890
Type
Rule
Action
Final order.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2016-07-26
Effective date
2016-07-26
HHS docket
Docket No. FDA-2000-N-0158
Abstract
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.