martes, 14 de junio de 2016

CDRH Industry: FDA issues Final Rule: “Use of Symbols in Labeling” – Webinar July 25, 2016

Today the Food and Drug Administration (FDA) issued a final rule “Use of Symbols in Labeling” allowing the use of stand-alone symbols in medical device labeling, without adjacent explanatory text.  The final rule seeks to harmonize the labeling requirements of U.S. and international regulatory bodies with respect to the use of symbols in device labeling.

This final rule is revising the medical device and certain biological product labeling regulations by explicitly allowing graphical representation of information (symbols) in labeling  (including labels) without adjacent explanatory text (“stand-alone symbols”).  A stand-alone symbol can be used if the symbol has been established as part of a standard developed by a national or international standards development organization (SDO) (referred to as a “standardized symbol”) and such standardized symbol is authorized for stand-alone use in labeling as part of a standard when a symbols glossary is included in the labeling for the medical device.

The FDA also published a new standards-recognition notice that modifies the Agency’s current list of recognized standards containing stand-alone symbols to extend the recognition of six standards and to recognize three new consensus standards containing many more stand-alone symbols.
WEBINAROn July 25, 2016, the FDA will hold a webinar to help Industry and patient groups understand this final rule and the new standards recognition notice. 

  • Date:   July 25, 2016
  • Time:   1:00 PM – 2:30 PM ET
  • To hear the presentation and ask questions:  Dial: 888-469-0937; 1-630-395-0219 for international callers;  Passcode: 1622312; Conference number: PW8827759
  • To view the slide presentation during the webinar:


Please save this date and join us for the webinar.  We look forward to hearing your questions and providing clarification. 


Center for Devices and Radiological Health
Food and Drug Administration

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