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CDRH Cracks Down on Misleading “Registration Certificates”

On March 3, Rear Admiral Sean Boyd, Director of the Office of Regulatory Programs at the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced an uptick in firms selling and issuing fraudulent “FDA registration certificates” which indicate that a medical device has been authorized, approved, cleared, or reviewed by the agency.  Some of these misleading certificates even included the agency’s logo, the establishment’s registration number, or screenshots indicating the company’s registration status. 


In response, the FDA sent letters to 25 firms directing them to stop producing and issuing the fraudulent certificates to medical device manufacturers, distributors, and sellers. 

To protect consumers against misleading and fraudulent medical device claims, the agency launched a webpage to help them ensure that the products they purchase are FDA-approved.  The page makes several key points:


  • When a facility registers its establishment and lists its devices in the Establishment Registration and Device Listing System, it does not mean that it or its devices have been approved, cleared, or authorized by the FDA.
  • The FDA does not issue device registration certificates to medical device facilities.  The agency also does not “certify” registration for registered and listed businesses.
  • Displaying fraudulent or misleading registration certificates which imply that a device has been approved or reviewed by the FDA constitutes misbranding under the Food, Drug, and Cosmetic Act.


The webpage also includes information on how to see whether a product has been approved, cleared, or authorized under an Emergency Use Authorization.


The FDA also has a policy governing the use of its logo, which forbids the private sector from using it and includes civil and criminal penalties for misuse.  Nevertheless, some companies, including a manufacturer of animal drugs, have used the logo on their websites or promotional materials. 


As discussed in an earlier blog post, FDA Issues Warning Letters Targeting COVID-19 (And Other) Products, the FDA has taken action against firms that use false and misleading promotional tactics to market their products.  Since the COVID-19 pandemic began to intensify in March 2020, the FDA has sent warning letters to 146 manufacturers of products claiming to prevent, treat, mitigate, diagnose or cure coronavirus.  As the pandemic continues, this number is likely to increase as some bad actors will attempt to gain a competitive edge by using illegal tactics to market their products.

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