March 3, 2021
The following quote is attributed to Rear Adm. Sean Boyd, director of the Office of Regulatory Programs at the FDA’s Center for Devices and Radiological Health:
“During the current public health emergency, the U.S. Food and Drug Administration 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 so-called ‘FDA registration certificates’, with some of these certificates even using the FDA’s logo. Today, the FDA is announcing that it has sent letters to 25 firms 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. 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.
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 how registration certificates that are not issued by the FDA are being used. We will continue to work with manufacturers and stakeholders to direct them to publicly available resources on medical devices and what is required when marketing medical devices to the American public.
Health care professionals and the public can check FDA’s Emergency Use Authorization (EUA) page for devices authorized during the public health emergency, as well as our Medical Device Databases page for medical devices approved or cleared to be marketed in the U.S. To report the suspected misuse of registration certificates, please visit Reporting Allegations of Regulatory Misconduct.”
- The FDA does not issue any type of device establishment registration certificate. Registration and listing with FDA does not denote approval or clearance of the establishment or its devices.
- The FDA sent letters to 25 firms that produce and issue “FDA registration certificates” to medical device companies (including manufacturers, distributors and sellers).
- The registration certificates often have the look of an official government document and many display the FDA logo. In the letters, the FDA is requesting that firms cease producing and issuing such certificates.
- Some device manufacturers and distributors have used registration certificates to create the misimpression that FDA has reviewed, approved, cleared or authorized their products.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation and for regulating tobacco products.