Use of Certain Symbols in Labeling
Information
Type
Proposed Rule
Regulated products
Medical Devices
Published
April 19, 2013
Last updated
April 19, 2013
Description
Document number 2013-09175. The Food and Drug Administration (FDA) is proposing to revise medical device and biological product labeling regulations to explicitly allow for the inclusion of stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard developed by a nationally or internationally recognized standards development organization (SDO) (referred to in this document as a "standardized symbol") and such standardized symbol is part of a standard recognized by FDA for use on the labeling of medical devices (or on a subset of medical devices), provided that such symbol is explained in a symbols glossary that contemporaneously accompanies the medical device. FDA is also proposing to revise prescription device labeling regulations to authorize the use of the symbol statement "Rx only" on the labeling of prescription devices.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)