FDA Cracks Down on “FDA-registered” Device Certificate Claims

March 29, 2021 – The FDA does not issue certificates to medical device companies that register their facilities with the agency, nor does the registration of a device facility denote that products made in that facility are approved, cleared or authorized by the FDA, so a recent increase in the number of companies selling devices while displaying “FDA registration certificates” has prompted the FDA to warn 25 companies that they need to “stop producing and issuing these certificates.”

In a March 3 statement, Rear Admiral Sean Boyd, director of the Office of Regulatory Programs at the FDA’s Center for Devices and Radiological Health, explained that his office “has alerted firms that produce and issue these certificates that some device manufacturers and distributors are using registration certificates to create the impression that FDA has reviewed, approved, cleared or authorized their products.”

The misleading impression created by these certificates – some of which use the FDA’s logo and look like government documents – is particularly concerning during “the current public health emergency” presented by the COVID-19 pandemic, Boyd states, when device buyers may be looking for such devices as masks, gloves and other protective gear to combat the virus.

The FDA’s website includes information for consumers about claims that devices are “FDA Registered” or “FDA Certified,” stating that “such words may be used to mislead you. Is that the same thing as FDA approved, FDA cleared or FDA authorized? The short answer is NO.”

“According to the news service AgencyIQ, a recent search for the term ‘FDA registered’ on turned up more than 7,000 results for various forms of medical equipment or devices,” noted Jon Bigelow, executive director of the Coalition for Healthcare Communication. “The FDA takes a dim view of this kind of misleading and deceptive marketing.”

The posting makes it clear that owners or operators of facilities involved in the production or distribution of medical devices intended for use in the Unites States are “generally required to register annually with the FDA.” However, that registration does not have anything to do with the regulatory status of products produced by that facility.

Accordingly, “Firms that misleadingly display certificated alongside information about and photos of a device for sale in the United States to imply review of approval by FDA of the device misbrand the device in violation of the Federal Food, Drug, and Cosmetic Act.” The agency instructs consumers to verify regulatory status of a medical device by:

  • Checking for approved and cleared products in the Devices@FDA Database;
  • Checking for products in the FDA’s de novo database (for new types of devices); and
  • Checking for emergency use authorizations for a device.

“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.,” Boyd states.