Prolong is regulated by different bodies around the world. In the U.S, it’s regulated by a little federal agency you may have heard of - the FDA (Food and Drug Administration). Prolong is regulated by the FDA’s Center for Devices and Radiological Health (CDRH), which is responsible for regulating firms who manufacture, repackage, re-label and/or import medical devices sold in the United States.
In order to get clearance to market, we had to supply some clinical performance data - AKA, a clinical trial. Independent trials were conducted in accordance with FDA’s Investigational Device Exemption (IDE)7 regulation. (And the results were pretty impressive.)
In Australia, Prolong is regulated by the Therapeutic Goods Administration (TGA). The TGA is part of the Australian Government Department of Health, and is responsible for regulating therapeutic goods including prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.