What triggers requirement for a medical device or drug manufacturer to be licensed?
Licensure requirements are required at the point that the medical device or drug use is intended for the diagnosis, cure, mitigation, treatment or prevention of disease in human beings or any other animal, or any article that is intended to affect the structure or any function of the body of human beings or any other animal. As described above in item 3, when a manufacturer is manufacturing medical devices or drugs for use in or on humans (whether clinical or commercial), a California manufacturing license is required. (Note: If a medical device or drug manufactured in California is intended for animal use for the diagnosis, cure, mitigation, treatment of prevention of disease, that drug or device is also required to be manufactured in a licensed drug or medical device facility.) The websites for on the FDB Medical Device Safety and Drug Safety programs, contain further details on the Sherman Law, and license applications.
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