Registrar Corp now provides Reporting, U.S. Agent, and Regulatory Compliance Assistance for U.S. and Non-U.S. Companies in the Radiation-Emitting Electronic Device Industry.
The U.S. FDA regulates Radiation-Emitting Electronic Devices intended for use in the United States by humans or other animals. U.S. FDA defines Radiation-Emitting Electronic Devices as “any product that contains an electronic circuit and generates any kind of radiation.” Radiation-Emitting Electronic Devices are manufactured or assembled products (or component, part, or accessory of such product) which, when in operation, contain or act as part of an electronic circuit and emits (or in the absence of effective shielding or other controls, would emit) electronic product radiation. “Electronic product radiation” is defined by the U.S. FDA as any ionizing or non-ionizing electromagnetic or particulate radiation, or any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product.
Examples of Radiation-Emitting Electronic Devices may include, but are not limited to, microwave ovens, televisions receivers and monitors, video displays, lasers, industrial x-ray systems, cordless and cellular telephones, industrial RF sealers of plastics and laminates, or laser CD players.
Some Radiation-Emitting Electronic Devices, such as diagnostic x-rays, ultrasound imaging devices, microwave or ultrasound diathermy devices, microwave blood warmers or sterilizers, laser coagulators, ultrasound phacoemulsifiers, x-ray or electron accelerators, sunlamps, or ultraviolet dental curing devices, are regulated by the U.S. FDA as both a Radiation-Emitting Electronic Device and as a Medical Device.
For information about how your product is regulated by the U.S. FDA, contact us and one of our expert regulatory advisers will assist you.