The Center for Devices and Radiological Health or CDRH is the branch of the Food and Drug Administration that is responsible in implementing the standards set for medical device regulation. According to the contents of the Food, Drug and Cosmetics Act (FD&C), medical devices are “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: recognized in the official National Formulary, or the United States Pharmacopoeia.” In a simpler perspective, medical devices are devices that save lives yet hazardous if not fully regulated. Medical devices are subject to General controls, premarket and post market regulatory controls. Thus, the CDRH of the Food and Drug Administration is the one that would facilitate the application of these three regulatory stages. Medical devices are properly evaluated to avoid making risks to human health as well as to the society where it is marketed.
