FDA Warns of Misleading Registration Certificates for COVID-19 Devices

The FDA is taking action against devicemakers that have been touting phony FDA registration certificates which give the false impression their products have received the agency’s clearance.

During the COVID-19 pandemic, the FDA has seen an increase in the number of companies selling devices “while deceptively indicating FDA’s approval, clearance, authorization or review through the use or display of so-called ‘FDA registration certificates’, with some of these certificates even using the FDA’s logo,” said Sean Boyd, director of the Office of Regulatory Programs at the FDA’s Center for Devices and Radiological Health.

The FDA’s Office of Regulatory Programs has sent letters to 25 manufacturers, distributors and sellers, telling them to stop producing and issuing these false certificates.