FDA calls on firms to stop producing misleading "FDA certificates"

March 4, 2021

The U.S. Food and Drug Administration (FDA) said it has seen an increase in the number of companies selling devices while deceptively indicating the agency’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, according to a news release from the agency.

As a result, the FDA said it has sent letters to 25 firms, telling them to stop producing and issuing these certificates.

“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,” said Rear Adm. Sean Boyd, Director of the Office of Regulatory Programs at the FDA’s Center for Devices and Radiological Health.

The FDA said it will continue to take appropriate steps to help ensure that the public is not misled about medical devices sold in the United States.

The FDA said healthcare professionals and the public can check the FDA's Emergency Use Authorization (EUA) page for devices authorized during the public health emergency, as well as its Medical Device Databases page for medical devices approved or cleared to be marketed in the United States.

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