You may have seen words like these on a website selling a medical device in the United States, sometimes even with the FDA logo:
- FDA Registered
- FDA Certified
- FDA Certificate of Registration
These words can be used to confuse you. Is it the same as FDA approved, FDA cleared, or FDA cleared? The short answer is NO. Here’s why.
FDA Registration
Owners or operators of places of business (also called establishments or facilities) involved in the production and distribution of medical devices intended for use in the United States are generally required to register annually with the FDA.
It is important to understand:
When a facility registers its facility and lists its devices, the resulting entry in FDA’s registration and listing database does not denote approval, clearance or clearance of that facility or its medical devices.
Are there FDA certificates?
When a company engaged in the production and distribution of medical devices intended for use in the United States registers with the FDA, it does not receive a certificate from the FDA.
It is important to understand:
FDA does not issue any type of device registration certificate to medical equipment facilities.
In addition, FDA does not “certify” the registration information of companies that have registered and have been listed.
Example of a fraudulent certificate
Misleading FDA registration certificates
Some companies sell medical devices in the United States along with “FDA certificates of registration,” such as the sample certificate shown here.
These certificates often look like an official government document and may include the FDA logo. However, FDA does not issue certificates of registration for devices and/or equipment.
Companies that deceptively display certificates along with information and photos of a device for sale in the United States to imply that FDA has reviewed or approved the device do so deceptively in violation of the Federal Food, Drug, and Cosmetic Act.