Manufacturing and Marketing Our Products. Our operations are not effected by seasonal factors. We are currently using researchers and consultants to staff our research facilities. We are not able to provide a reasonable estimate of the number of any additional researchers, consultants or employees which may be needed at this time. Summary of Research and Development Activities.
Confusion sometimes exists between unregulated consumer products and medical devices.
Products are not considered medical devices if they have general utility and are not dedicated to medical applications. Such products are subject to the Consumer Product Safety Act. Human therapeutic products are subject to rigorous pre-clinical and clinical testing and other approval procedures. Various federal, state and foreign statutes may also govern or affect the manufacturing, safety, labeling, storage, and marketing of such products, as well as record-keeping incidental to such marketing. The 1997 Act also directs the FDA to concentrate its postmarket surveillance on higher risk devices.