Manufacturer

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

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 insigns 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 […]

Keep Calm and FSMA Doc On!

The Food Safety Modernization Act (FSMA) is the Food and Drug Administration’s (FDA) most comprehensive reform of food safety regulation.  The full Act can be found here.  The FDA’s main goal is to make food safer through every step of the process, starting at farms.  Imported food is also covered under FSMA, which makes sense as imported food now accounts for approximately 15% of food consumption in the U.S.  Rather than focusing on the inspection and response to contamination, the goal of the FSMA is to prevent contamination.  Diaz Trade Law covered the changes on June 11, 2015 here.

President Obama signed the FSMA into law on January 4, 2011.  FSMA will be implemented slowly in a staggered manner and will be fully implemented by the end of 2017.  Implementation varies based on the particular food, company size, and situation, since the FSMA applies to such a broad category.  Diaz Trade Law can assist you in learning the basic requirements for FDA regulated products here.

Companies affected by the FSMA will be any company in the food supply chain.  Any company that imports, distributes, grows, produces, packages, transports or sells any type of food must be compliant.  The company that owns the food is the company responsible for creating a food safety plan.  That means that companies that store, carry, or transport the food do not need a food safety plan, but they still must be FSMA compliant.

Diaz Trade Law has compiled 3 top tips to successfully follow […]

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