The FDA has written to 25 companies - including manufacturers, distributors and sellers - telling them not to produce false device certification documents
The US FDA has sent letters to 25 companies warning them to stop producing false certification documents for medical devices.
During the ongoing public health crisis, the regulator says it has seen an increased number of firms deceptively claiming to have received FDA approval for the products they’re selling.
In a statement, Rear admiral Sean Boyd – director of the Office of Regulatory Programs at the FDA’s Center for Devices and Radiological Health – said the list of companies issuing these “FDA registration certificates” includes manufacturers, distributors and sellers.
These misleading documents “often have the look of an official government document”, and some even bear the American regulatory body’s logo.
“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,” Boyd added.
“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 the FDA has reviewed, approved, cleared, or authorised their products.
“The FDA will continue to take appropriate steps to help ensure that the public is not misled about medical devices sold in the US.
“The FDA’s priority is protecting public health, and we intend to take action when misleading or deceptive practices could harm consumers.
“Device manufacturers and other stakeholders need to be aware of how registration certificates that are not issued by the FDA are being used.”
The regulator also stated that healthcare professionals and the public can check the FDA’s online list of devices given Emergency Use Authorisation (EUA) for use during the current public health emergency, as well as referencing its Medical Device Databases for devices cleared to be marketed in the US more generally.
Anyone looking to report the suspected misuse of FDA registration certificates has been told to do so via a Reporting Allegations of Regulatory Misconduct form.