FDA “Requests” Fraudsters to Stop Making Fake Certificates
​(Thursday, March 4, 2021)
FDA released a strange email “request” today to firms issuing misleading “FDA Registration Certificates” that look like government documents and include FDA’s logo. FDA is aware that such certificates, which are very common for Class I medical devices, are used to deceive consumers to think a device is approved by FDA based on an establishment’s FDA registration number. FDA registration of medical device manufacturer is an almost automated online process where anyone can register a company, with practically no review by FDA, by paying the annual registration fee of about $5000. For Class I medical devices, that is all one needs to do to legally sell such medical devices or import them from other countries in the US. Due to the lax review of the device registration information, its database contains many errors in the information. Last year it was found that more than 1300 manufacturers in China used a fake US agent to register with the FDA and were caught due to an accidental discovery. So, why does FDA not prosecute issuers of fake and misleading “FDA Registration Certificate”? Because it probably can’t. The issuers of “FDA Registration Certificates” are permitted to do that under Freedom of Speech laws. They are careful to include disclaimers in the certificate, albeit carefully printed to avoid prominence, and contain truthful information about the manufacturer’s legal status regarding the medical devices sold by them. Theses certificates may be unethical and misleading, but they are not illegal. So, besides making a “request” to these issuers of certificate, FDA has to wait for them to push the envelope further and make illegal claims. Meanwhile, FDA can do better job of educating consumers about such registration certificates, so consumers are aware that these are not issued by FDA. Also, when a certificate contains the FDA logo, or any other logo from a Federal agency, it should take strong action against them. Easier said than done, perhaps.

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AUTHOR               

 Dr. Mukesh Kumar
​ Founder & CEO, FDAMap

 Email: [email protected]
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