The U.S. Food and Drug Administration (FDA) is aware that some companies are producing and issuing “FDA registration certificates” that may appear to be official government documents and include unauthorized use of the FDA logo. FDA is also aware that some certificates of registration are being used in a misleading manner to confuse the branding of medical devices in violation of the Federal Food, Drug, and Cosmetic Act. For example, the display of a registration certificate next to information and photos of a device may mislead consumers into thinking that a device was reviewed and approved by FDA based on a facility’s registration or possession of a registration number. FDA has asked these companies to stop producing and issuing registration certificates.
Registration Certificate to Medical Device
FDA’s Center for Devices and Radiological Health (CDRH) does not issue any type of device registration certificate to medical device establishments. When an establishment registers and lists its devices, the resulting entry in FDA’s establishment registration and device listing database does not indicate anything other than the fact that the establishment has provided certain information to FDA. Since the registration information is publicly available on FDA’s website, there does not appear to be any purpose for a registration certificate other than to imply FDA’s approval, clearance, authorization, certification, endorsement, or other evaluation of the establishment or device. FDA will continue to monitor the use of certificates of registration.