Companies warned about misleading “FDA registration certificates.”

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Posted 07 July 2021

The FDA has ordered 25 companies to stop issuing documents that state that a medical device has been registered with the FDA. The certificates often look like official government documents, and many display the FDA logo. The agency believes that the certificates falsely imply that a device has been evaluated, cleared, or approved as effective for its intended purposes. The FDA does not issue any type of device registration certificate, and registration does not denote approval or clearance of a manufacturer or its devices. It merely means that certain information has been provided to the FDA.
Reference: Barrett S. FDA orders 25 companies to stop issuing misleading “FDA registration certificates.” Device Watch, July 4, 2021

The marketers of Healy bioresonance devices are using a certificate which states that their device has been cleared. Although the recent FDA action concerned registration certificates, the same principles appear applicable to “clearance certificates.” Reference: Barrett S. A skeptical look at the Healy “bioresonance” device. Device Watch, July 4, 2021

Source: Consumer Health Digest #21-26 July 4. 2021

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