It seemed like a surplus of the “FDA Registration Certificates” were being presented by Chinese manufacturers of face masks and other personal protective equipment (PPE), at the beginning of the Covid-19 pandemic. These served as evidence of companies’ products were listed correctly and registered with the Food and Drug Administration (FDA). A false sense of security for companies seeking to import PPE products from China may have been created.
It has been a year, but FDA has finally taken action against firms from issuing misleading “FDA Registration Certificates.” The agency announced on 3rd March 2021 that it sent letters to 25 firms to stop producing and issuing these certificates.
The announcement stated that the FDA does not issue any type of registration certificates to medical device establishments who register using the Establishment Registration & Device Listing system. The Office of Regulatory Programs also alerted the firms that produce and issue certificates that some companies use registration certificates to create the misimpression that the FDA has cleared, authorized, reviewed, or approved their products.
The FDA also took time and reminded companies about its logo policy because some of the FDA Registration Certificates included the FDA logo. The Logo policy states: the agency’s logo “is for official use of the [FDA] and not for use on private sector materials.”