The FDA rigidly controls the radiation emitting devices to check if or not they are for medical application. These devices incorporate x-ray machines, ultrasound devices used in hospitals and clinics. Not just that the lasers employed in laser light shows, infrared as well as ultraviolet lamps and equipment, microwave ovens and every radiation emitting machines are regulated austerely by FDA. FDA has authority to regulate the devices even if the devices produce radiation within the shield provided. Moreover precise certification as well as labeling related to the devices, in addition to the consumer manual being significant information for clients, FDA demands definite warnings as well as declarations to incorporate them explicitly for the application.
The non-U.S manufacturer as well as importer of Radiation-emitting devices must submit comprehensive Electronic Product Initial Report to FDA; it carries detailed evaluations of the same. The manufacturers have to as a mandatory factor engage a U.S. Agent for FDA for filing the initial reports of their products to FDA.