FDA official clarifies difference between FDA registration and FDA certification

Release time:

2021-03-16 14:22

You may have seen these words on the packaging of the product, sometimes even with the FDA logo: FDA registered, FDA certified, FDA registered certificate, and so on. These words may be used to mislead you. Is this FDA-approved or FDA-authorized? The short answer is no. Recently, the US FDA officially announced the difference between FDA registration and FDA certification.

FDA Registration

Factories or companies involved in the production and distribution of medical devices for use in the United States are typically required to register with the FDA annually.

When a facility conducts FDA "company registration and product listing", it does not imply approval, licensing, or authorization of the facility or its medical devices. When companies involved in the production and distribution of medical devices for use in the United States register with the FDA, they are not required to obtain a certificate from the FDA.

Focus:

The FDA does not issue any type of device registration certificate to medical device companies or factories. In addition, the FDA does not "certify" registration information for registered and marketed businesses.

Fraud Certificate Example: Some companies sell medical devices in the United States with an "FDA Registration Certificate" such as the example certificate described here. These certificates often have the appearance of official government documents and may include the FDA logo. However, the FDA does not issue device registration certificates. They misleadingly display certificates with information and photos of devices sold in the U. S.

How do you know if the FDA has approved or authorized a medical device?

The FDA offers several ways for you to check if the FDA has approved or authorized a medical device

1. Check the products in the Devices @ FDA database: Devices @ FDA is FDA's medical device information directory. You can search for FDA-approved products by device name or company name

Check products in the De Novo database: FDA may review medical devices through the De Novo premarket review pathway, a regulatory pathway for new low-to medium-risk devices. Devices reviewed through this route may be authorized for marketing in the United States.

3. Xinanrun Consulting provides FDA registration, EPA registration and FDA inquiry services.

What is Emergency Use Authorization EUA

Emergency Use Authorization (EUA): In certain types of public health emergencies, such as during a new crown, when the Secretary of Health and Human Services declares that there are circumstances justifying approval for emergency use of a medical device, FDA may issue an Emergency Use Authorization (EUA) authorizing an unapproved medical product or an unapproved medical product to be used in an emergency to diagnose, treat, or prevent a serious or life-threatening disease or condition.

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