FDA has sent letters telling 25 companies to stop producing "registration certificates" to falsely create the impression the agency has reviewed, approved, cleared, or authorized medical device products.
The certificates typically look like official government documents and in many cases feature the FDA logo. However, the agency does not issue any type of device establishment registration certificates.
FDA took action against the companies that produce and issue such bogus documents after identifying an increase in the use of materials "deceptively indicating" it had assessed medical devices during the COVID-19 pandemic.
The surge in demand for personal protective equipment, diagnostics and other medtech products as the coronavirus spread quickly around the world created opportunities for bad actors to make up for shortfalls in the supply of authorized medical equipment. Amid those opportunities, regulators clamped down to stop the supply of unauthorized products. Australia’s Therapeutic Goods Authorization, for example, has issued a steady stream of fines.
Now, FDA has disclosed its actions against companies that sell devices while "deceptively indicating FDA's approval, clearance, authorization or review," Sean Boyd, director of the Office of Regulatory Programs at FDA's Center for Devices and Radiological Health, said in a statement.
Boyd said the companies use or display "so-called 'FDA registration certificates'." The documents look like official government paperwork that indicate FDA has in some way reviewed a product. However, while FDA does register companies through its Establishment Registration & Device Listing system, it does not issue certificates to organizations in the system.
Having identified an uptick in the use of potentially misleading certificates during the pandemic, FDA wrote to 25 companies that produce and issue such documents to medtechs. The letters state "some device manufacturers and distributors are using registration certificates to create the misimpression that FDA has reviewed, approved, cleared, or authorized their products," Boyd said.
The agency issued the statement on the same day as launching a consumer-focused website to explain that terms such as FDA Registered, FDA Certified and FDA Registration Certificate can be used to mislead the public. The website states those terms do not indicate a product has been approved, authorized or cleared by the agency.
If a consumer wants to know the regulatory status of a device, FDA is encouraging them to search its databases and check the list of products granted emergency use authorization during the pandemic.