The Food and Drug Administrations (FDA) and Center for Devices and Radiological Health (CDRH) governs companies who manufacture, relabel, repackage, or import medical devices sold in the United States. CDRH regulates electronics that emit radiation both medical and non-medical... such as lasers, x-ray systems, or ultrasound equipment. Medical devices are classified into classes (I, II, III). Assigned regulatory measures increases by class levels. Device regulations defines regulatory requirements for device groups. Manufacturers both domestic and foreign, and initial distributors (importers) of medical devices must register with the FDA. All established registrations must be granted by FDA's approval.