Medical Devices: Use of Certain Symbols in Labeling--Glossary to Support the Use of Symbols in Labeling

OMB 0910-0740

OMB 0910-0740

FDA medical device and biological product labeling regulations provide that a stand-alone symbol is allowed to be used in device labeling if the symbol is established in a standard developed by a standards development organization (SDO); is contained in a standard that FDA recognizes for use in the labeling for devices, or, alternatively, is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use; and is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement about the location of the symbols glossary. The use of symbols, accompanied by adjacent explanatory text continues to be permitted. Additionally, FDA prescription device labeling regulations authorize the use of the symbol statement “Rx only” in the labeling for prescription devices.

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