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. 

Most Class I devices and a few Class II devices are exempt from the requirement for submission of a marketing application in the USA. However, these devices are not exempt from other general controls. All medical devices must be manufactured under a quality assurance program, be suitable for the intended use, be adequately packaged and properly labeled, and have establishment registration and device listing forms on file with the FDA. A few Class I devices are additionally exempt from the GMP (Good Manufacturing Practice) requirements, with the exception of complaint files and general record keeping requirements.

"Class I devices are subject to "General Controls". General controls include provisions that relate to adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices. Class I devices are not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury. Most Class I devices are exempt from the premarket notification and/or good manufacturing practices regulation."

In South Africa medical devices are regulated as part of the Medicines and Related Substances Act by the Medicines Control Council (MCC), so any claims relating to the FDA are essentially irrelevant.

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