Copy of a FDA registration certification letter.

The U.S. Food and Drug Administration has taken action against a niche printing industry that has been misleading consumers about the safety and efficacy of certain medical devices. The FDA announced last week that it sent letters to 25 printing firms to stop producing fake “FDA registration certificates.” 

Medical devices” is a term used in specific ways by the FDA. It includes everything from consumer health care products such as bandaids, thermometers, and hydrogen peroxide to surgically implanted devices such as pacemakers, breast implants and artificial joints. According to the FDA, some companies are attempting to use the FDA’s preoccupation with the global pandemic to pass off unregulated and unapproved medical devices as legitimate.

The FDA said that some medical device manufacturers, distributors, and sellers have purchased these fake FDA certificates and used them to market their products. The agency noted that this type of fraudulent activity has been on the rise since the start of the COVID-19 pandemic.

The fake certificates look like official government documents, even displaying the FDA logo in many cases. The FDA stressed that these certificates are in no way associated with the agency, nor do they indicate the safety or reliability of the untested and unregulated products being sold.

Alongside the March 3 announcement, the FDA launched an online guide to help consumers understand the facts about the current fraud and how to identify legitimately approved medical products. For instance, consumers are advised to be on the lookout for the following types of false claims on websites selling medical devices:

  • FDA Registered
  • FDA Certified
  • FDA Registration Certificate

What Consumers Can Do To Protect Themselves

To learn how to verify whether a medical product has received genuine approval, clearance or authorization from the FDA, please refer to our article "New Guide Teaches Consumers How to Verify FDA Approved Medical Products."