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FDA Class I devices

A number of products in South Africa, e.g., 8ight LLC Hologram Powerband, claim that they work because they are registered with the American FDA as a Class I Device. This claim is highly misleading.

Class I Device registration has absolutely nothing to do with efficacy of a product (whether it works). 

Class I device registration is simply a register of products being marketed in the USA that fall within a particular category, i.e., Class I devices are subject to the least regulatory control. The higher the level, the more proof of safety and efficacy is required.

Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments. 

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