Biologics

FDA to Allow Standalone Labeling Symbols

FDA has issued a final rule to explicitly allow for optional inclusion of standalone symbols without adjacent explanatory text in labeling for medical devices and certain biological products if certain conditions are met. The rule also specifies that using symbols, accompanied by adjacent explanatory text, continues to be permitted.

The document says that the medical device industry asked for the ability to use standalone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets. “The final rule seeks to harmonize the U.S. device labeling requirements for symbols with international regulatory requirements,” it says.

Under the new rule, symbols established in a standard developed by a standards development organization may be used in medical device labeling without adjacent explanatory text as long as (1) the standard is recognized by FDA and is used in accordance with FDA requirements; (2) if the symbol is not included in a standard recognized by the agency or is in a standard recognized by FDA but is not used according to regulatory specifications, the device manufacturer otherwise determines that the symbol is likely to be read and understood by an ordinary individual under customary conditions of purchase and use, and uses the symbol according to the specifications in the standard it is following. Also, the document says, in either case the symbol must be explained in a paper or electronic symbols glossary that is included in the medical device labeling. And the labeling on or within the packaging containing the device must have a prominent and conspicuous statement identifying the location of the symbols glossary.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome