Medical devicemakers warned against use of misleading labels suggesting FDA approval

The FDA said March 3 that some medical devicemakers have been displaying "FDA registration certificates" on their products, such as masks and face shields, to suggest the products are FDA-approved, but the agency doesn't distribute such certificates. 

"During the current public health emergency, 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 a so-called 'FDA registration certificate,' with some of these certificates even using the FDA's logo," Rear Adm. Sean Boyd, a director in the FDA's Center for Devices and Radiological Health, said in a news release. 

The agency said it has sent letters to 25 companies telling them to stop producing and issuing the certificates.

The FDA doesn't issue any kind of device establishment registration certificate, it said. 

The FDA said healthcare providers can check the FDA's emergency use authorizations and medical device databases for authorized or approved devices. 

"The FDA will continue to take appropriate steps to help ensure that the public is not misled about medical devices sold in the U.S.," Mr. Boyd said. 

Read the FDA's full news release here.

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