FDA Launches New Webpage to Promote Use of Symbols in Medical Device Labeling

Today the U.S. Food and Drug Administration (FDA) launched a new webpage to assist the public understand the Use of Symbols in Labeling Final Rule. The final rule was issued by the FDA in June 2016 and became effective three months later.

FDA intends the final rule to be an attempt to “harmonize the U.S. device labeling requirements for symbols with international regulatory requirements. As the medical device industry has requested the ability to use stand-alone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets.” This is exciting news for our clients who are Medical Device Manufacturers or Importers – as of September 2016 all medical device labeling may use stand-alone symbols!

What does the Use of Symbols in Labeling Final Rule provide for?

  • Permits the use of symbols in all medical device labeling without adjacent explanatory text. This means “stand-alone symbols” may be used, but only if certain requirements are met.
  • Stipulates the use of symbols, accompanied by adjacent explanatory text is still permitted. This means companies are not required to relabel their products, even if they meet the requirements for the use of “stand-alone symbols”.
  • Revises prescription device labeling regulations, now permitting to use the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.
  • The final rule does not apply to product graphics or pictograms, such as graphics showing the steps for using a device.

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Do You Keep Your Manifest Information CONFIDENTIAL?

Did you know importers and consignees can request that U.S. Customs and Border Protection (CBP) keep your manifest information confidential? If you are currently letting your competitors know your source, read on, and learn how to keep your private data private!

On February 1, 2013 Many Food Facilities Face Suspension

Are you a company that manufactures/processes, packs, or holds food, alcoholic beverages, and/or dietary supplements for consumption in the U.S.? If so, have you re-registered your food facility with the U.S. Food and Drug Administration (FDA)? FDA extended the deadline for the biennial registration renewal for food facilities until January 31, 2013. Your time is almost up to re-register! If your not re-registered, enforcement will begin on February 1, 2013. FDA will cancel your Bioterrorism Act registration and your importations will be significantly delayed. Your facility will NOT be able to import, distribute or sell food products in the U.S.

By |2021-11-10T14:27:13-05:00January 22, 2013|Food, FSMA, U.S. Food and Drug Administration (FDA)|Comments Off on On February 1, 2013 Many Food Facilities Face Suspension
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