How do I verify FDA certification?

What does FDA certified mean?

FDA stands for the Food and Drug Administration, a government agency responsible for the safety of food, dietary supplements, human drugs, vaccines, blood products and other biologicals, medical devices, radiation-emitting electronics, cosmetics, veterinarian products and tobacco products being sold or manufactured in the United States. The FDA also inspects and enforces regulations related to these industries.

Organizations that manufacture, re-pack or re-label products in the aforementioned industries must register with the FDA, with the exception of cosmetics, where registration is voluntary.

The registration process varies dependent on the industry but generally involves an annual registration in which organizations are required to list all drugs being manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Inspection results for FDA registered organizations are available on the FDA website.

Is FDA certified the same as FDA approved?

No, they are not. A lot of the masks nowadays claimed that they are "FDA approved." FDA do not approve mask, companies nor products, as stated in here.

One exception would be the FDA Emergency Use Authorization (EUA) approved. During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.

Therefore, if you are seeing any listing that is claiming FDA approved, avoid it at all costs.

I am seeing the FDA Certificate of Registration, how do I verify if it is authentic?

  1. Go to fdahelp.us, under the category “medical device," choose search by operator number (they are the number that can be easily found on each certificate, as the certificates are issued to a specific company, not just a product)
  2. On Owner/Operator Number field, enter the number you see on FDA certificate and click search.

For our manufacturers, you are able to find the operator number on the certificate itself. We have also included a link toward each FDA certificate result on the product listing page. 

Putting it on a test

For example, let's put Ning Rui Medical's FDA certificate on the test.

1. Locate the FDA certificate and the operator number.

2. Locate the owner/operator number: 10065640

3. Enter and search

4. You will clearly see that Ning Rui Medical is registered with FDA!

What if I don't know the operator number?

If you don't know the operator number of the manufacturer, you can still look up by searching the manufacture's name under Establishment or Trade Name.

I have heard the term FDA and CE certified, how can I verify CE certificate?

Although CE certifications are not able to verify through the FDA, you are able to get more information from the official Europe Commission website.

 

References:

1. “FDA Registered Certification Definition: What Is FDA Registered?: Find FDA Registered Companies on ThomasNet.com® Supplier Diversity Quality Discovery.” What Is FDA Registered? | Find FDA Registered Companies on ThomasNet.com® Supplier Diversity Quality Discovery, certifications.thomasnet.com/certifications/glossary/other-certification_registration/fda/fda-registered/.

2. Commissioner, Office of the. “FDA Fundamentals.” U.S. Food and Drug Administration, FDA, www.fda.gov/about-fda/fda-basics/fda-fundamentals.

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