Misbranding is a serious issue in the healthcare industry. For all the claims, indications for use, and other labeling details accompanying the product there must be some supporting data on file to avoid misbranding of your device. Misbranding can result in inadvertent misuse and potential adverse events. 

Example of misbranding

An example of this is the general Thermal Imaging product, widely used since COVID 19. The inappropriate course of action can sometimes result from the use of misbranded thermal imaging devices, posing a risk to public health. The FDA is providing crucial information to consumers, healthcare providers, and other users regarding the proper use of these devices as a part of the FDA’s continuous commitment to transparency to the American public. 

Following are recommendations for the Manufacturers to provide to the customers, healthcare practitioners, and other users when using thermal imaging systems:

  • Not used for mass temperature screening – users must be aware of what is the real use  
  • Not used to diagnose COVID-19 – ensuring that the indications for use is clear
  • Not used for detection of other diseases unless clearly indicated and approved for such a use 
  • Employed only for initial temperature assessment 

Warning letters issued for misbranding

FDA is issuing warning letters to certain firms/manufacturers associated with misbranded and adulterated products. Such warning letters are made publicly available and oftentimes affect the credibility of the company receiving them, negatively impacting the overall brand.  

How to avoid misbranding? 

In order to avoid misbranding manufacturers must include information to help with the accurate use and prevent misuse of their product. Much of this information could be guided by the hazard analysis, usability, and other aspects of the product and its application. Manufacturers must ask themselves: 

  • Who is the target user of this product? 
  • Is the information provided in the labeling sufficient for them to aptly use the device? 
  • Is there sufficient data on file that can support the clinical or other claims that are being made for the product? 
  • Does the device have performance, and verification and validation testing are required to justify that it works as intended?
  • Were the right certifications and approvals pursued for the product and label consistent with the same?  

Often misbranding can be an honest mistake by the manufacturer, as they may not always know what labeling is apt for their product. However, it is important that the Manufacturers take the first step to ensure that their product is labeled appropriately by getting a thorough labeling review from an Expert. To learn more about what should or should not be included in the labeling of your product, contact jennifer@elexes.com today. 

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Elexes Team

Elexes medical consulting is one of the leading regulatory & compliance consultant for several industries: Medical device, Pharmaceuticals, Cosmetics, Food, and Biologics.

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