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FDA officially clarifies the difference between FDA registration and FDA certification

You may have seen such words on the packaging of goods, sometimes even with the FDA logo: FDA registration,

American Food and Drug Administration certification, FDA registration certificate, etc. These words may be used to mislead you. Is this approved or authorized by FDA? The short answer is no. Recently, 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 usually need to register with FDA every year.

When a factory carries out FDA "company registration and product listing", it does not mean the approval, license or authorization of the factory or its medical devices. When companies involved in the production and distribution of medical devices used in the United States register with FDA, they do not need to obtain a certificate issued by FDA.

Focus:

FDA does not issue any type of equipment registration certificate to medical device companies or factories. In addition, FDA does not "certify" registered information for registered and listed enterprises.

Example of fraud certificate: Some companies sell medical devices in the United States with "FDA registration certificate", such as the example certificate described here. These certificates usually have the appearance of official government documents and may include the FDA logo. However, FDA does not issue equipment registration certificates. They misleadingly display certificates together with information and photos of equipment sold in the United States.

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How do you know if FDA approves or authorizes medical devices?

The FDA provides several methods for you to check whether the FDA approves or authorizes medical devices

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

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. Check the products in the database of De Novo: FDA may examine medical equipment through the pre-marketing examination of De Novo, which is a regulatory approach for new medium and low risk equipment. Equipment reviewed through this channel may be authorized for marketing in the United States.

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

What is emergency use authorization EUA

Emergency Use Authorization (EUA): In some types of public health emergencies, such as in COVID-19, when the Minister of Health and Human Services announces that there is reason to approve the emergency use of medical devices, FDA can issue an emergency use authorization (EUA) to authorize unapproved medical products or unapproved medical products to be used in emergency diagnosis, treatment or prevention of serious or life-threatening diseases or conditions.


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