WASHINGTON, D.C. — In a statement issued this week, the U.S. Food and Drug Administration (FDA) noted that it is aware that certain companies are producing and issuing “FDA Registration Certificates” that may look like official government documents and include unauthorized use of the FDA logo. The FDA is also aware that “some registration certificates are being used in misleading ways that misbrand medical devices in violation of the Federal Food, Drug, and Cosmetic Act”.
For example, display of a registration certificate alongside information and photos of a device may mislead consumers to think a device was reviewed and approved by the FDA based on an establishment’s registration or possession of a registration number.
The FDA has requested these firms stop producing and issuing the registration certificates.
“The FDA’s Center for Devices and Radiological Health (CDRH) does not issue any type of device registration certificates to medical device establishments. When an establishment registers and lists its devices, the resulting entry in FDA’s Establishment Registration & Device Listing Database does not indicate anything other than that the establishment has provided certain information to FDA. Because registration information is publicly available on the FDA’s website, there does not seem to be any purpose for a registration certificate other than to imply FDA approval, clearance, authorization, certification, endorsement, or other evaluation of the establishment or device. The FDA will continue to monitor the use of registration certificates.”
In the statement, the FDA states that it makes information about listed medical devices publicly available. This Registration and Listing information is listed on the Medical Devices Databases page.
Response from Hearing Industry
“Hearing is essential. Hearing aids are advanced technology medical devices regulated by the FDA since 1977,” commented Hearing Industries Association (HIA) Chairman, Brandon Sawalich. “HIA embraces our responsibility to the FDA to design and manufacture hearing aids with patient safety, care, and satisfaction top of mind.”
“The Hearing Industries Association works every day to ensure patient safety and acts to educate the public and elected officials responsible for our laws and regulations. We are seeing some companies falsely imply that FDA registration connotes FDA approval. Our members are deeply invested in innovation but not at the cost of misleading consumers.”
–Kate Carr, HIA President