Not Worth the Paper It’s Printed On: FDA Calls Companies to Stop Issuing Misleading Medical Device Establishment Registration Certificates

Footnotes for this article are available at the end of this page.

At the beginning of the COVID-19 pandemic, we saw what seemed to be a surplus of “FDA Registration Certificates” being presented by Chinese manufacturers of face masks and other personal protective equipment (PPE) as evidence that the products and companies were properly listed and registered with the Food and Drug Administration (FDA). These registration certificates may have created a false sense of security for companies seeking to import PPE products from China. As we now know, there were so many issues with PPE imported from China that FDA ultimately reversed its position and stopped the importation of a large number of face masks, widely known as KN95s (see our previous Bulletin here). When advising clients, we had to explain that these certificates were meaningless (i.e., the fact that these companies were registered and that products were listed did not mean that FDA had in any way approved or endorsed the product or the company). In fact, in many cases, the product listings were not legitimate, but more of a way for companies to try to get their products through U.S. Customs and Border Protection.

It took a year, but FDA has finally taken action to try to stop certain firms from issuing misleading “FDA Registration Certificates.” On March 3, 2021, the agency announced that it had sent letters to 25 firms to stop producing and issuing these certificates.1 In the announcement, it stated:

To be clear, the FDA does not issue any type of registration certificates to medical device establishments that register with the agency using our Establishment Registration & Device Listing system.  The Office of Regulatory Programs has alerted firms that produce and issue these certificates that some device manufacturers and distributors are using registration certificates to create the misimpression that FDA has reviewed, approved, cleared, or authorized their products.

The agency also took the time to remind companies of its logo policy because some of the certificates included the FDA logo on them. FDA’s logo policy clearly states that the agency’s logo “is for official use of the [FDA] and not for use on private sector materials.”

In addition, FDA also issued a new webpage, titled “Are There “FDA Registered” or “FDA Certified” Medical Devices?  How Do I Know What Is FDA Approved,” that specifically states that, “[w]hen a facility registers and lists its devices, the resulting entry in the FDA’s registration and listing database does not denote approval, clearance, or authorization of that facility or its medical devices.” FDA also emphasized that it “does not issue any type of device registration certificates to medical device facilities.”  Finally, the agency also explained that firms that misleadingly display certificates alongside information about and photos of a device for sale in the United States to imply review or approval by FDA of the device “misbrand the device in violation of the Federal Food, Drug, and Cosmetic Act.”

The agency provides directions for checking whether a company’s product has been cleared, approved, or authorized for sale. Companies can search the Devices@FDA Database to find a product’s regulatory status.

AGG Observations

  • While FDA noted that it issued “25 letters,” these letters have not been posted by the agency. It may be that, because they were issued against companies that assist with the preparation of registrations and listings, FDA may not have the authority to take enforcement action directly against these service providers. Thus, it is unclear whether FDA will be able to take formal action and, if so, on what grounds.
  • FDA did not address the issue of fraudulent device listings. This was an issue that our firm came across when reviewing product listings for imported facemasks, particularly with N95s.  It will be interesting to see whether FDA will eventually review its registration and listings database and require that companies update their listings accordingly.
  • A year into the pandemic, the threat of fraudulent products and companies seeking to mislead consumers is still as real as it was a year ago. As we start to find a new normal, and the agency has more resources available, we expect that FDA will continue to take enforcement actions to protect consumers.

 

[1] See FDA in Brief:  FDA Calls on Certain Firms to Stop Producing and Issuing Misleading “FDA Registration Certificates,” available at https://www.fda.gov/news-events/fda-brief/fda-brief-fda-calls-certain-firms-stop-producing-and-issuing-misleading-fda-registration.

[2] See FDA’s Logo Policy, available at https://www.fda.gov/about-fda/website-policies/fda-logo-policy.

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