Use of Symbols in Labeling - FDA
The final rule permits the use of symbols in all medical device labeling without adjacent explanatory text (referred to as "stand-alone symbols") if certain requirements are met.
Use of Symbols in Labeling: Frequently Asked Questions | FDA
Manufacturers may revise their use of symbols in labeling as authorized by the final rule during their next labeling update. The FDA expects manufacturers developing new labeling to use stand...
FDA Name and Logo Policy | FDA - U.S. Food and Drug Administration
Aug 31, 2023 · The “FDA” name, an initialism for the U.S. Food and Drug Administration, and corresponding logos are trademarks and service marks (hereinafter, “FDA Marks”) specifically for the official ...
eCFR :: 21 CFR Part 801 -- Labeling
Automatic identification and data capture (AIDC) means any technology that conveys the unique device identifier or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process.
Recognized Consensus Standards: Medical Devices - Food and …
This document is applicable to symbols used in a broad spectrum of medical devices, that are available globally and need to meet different regulatory requirements. These symbols can be used on...
21 CFR 801.15 -- Medical devices; prominence of required label ...
§ 801.15 Medical devices; prominence of required label statements; use of symbols in labeling. ( a ) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:
FDA Issues Final Rule Permitting Use of Symbols on Device …
Jun 16, 2016 · FDA also made the final rule more meaningful by, on the same day, updating its list of recognized standards to include several medical device symbols standards including, among others, ISO 15223 – Medical devices—symbols to be used with medical device labels, labelling, and information to be supplied—Part 1: General requirements.
FDA Label Search
Download All Labels. Health information suppliers and others can download all of the electronic files companies have submitted from the National Library of Medicine’s Download Labels site....
Federal Register :: Use of Symbols in Labeling
Jun 15, 2016 · Accordingly, this final rule provides that a stand-alone symbol is allowed to be used in device labeling if: (1) The symbol is established in a standard developed by an SDO; and (2) the standard is recognized by FDA under its authority under section 514(c) of the FD&C Act and the symbol is used according to the specifications for use of the ...
Will new FDA final rule on symbols for device labels make devices ...
Aug 3, 2016 · In June, FDA finally dropped their requirement for symbols for device labels to be explained with adjacent text and now allows the use of standalone symbols on medical device and In Vitro Diagnostic (IVD) labels as long as certain requirements are met.
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