FDA Issues Final Rule Allowing Symbols On Device Labels

By Dani Kass (June 14, 2016, 3:41 PM EDT) -- The U.S. Food and Drug Administration on Tuesday released its final rule allowing medical device manufacturers to use symbols, without accompanying text, on labels, permitting greater freedom to companies to decide what symbols are acceptable than the agency had initially proposed.

Under the rule set to be published in the Federal Register on Wednesday, manufacturers will be allowed to use symbols without an accompanying written explanation if they are included in standards set by a standards development organization, some of which are already recognized by the FDA. For those not recognized by the agency, manufacturers will be allowed to decide based...

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