Special Issues for Radiation-Emitting Devices

Particularly pertinent for lasers, any device that emits radiation must additionally com­ply with the Radiation Control for Health and Safety Act passed in 1968,72 which is also administered by the FDA and which authorizes the development of performance standards and general controls for ionizing radiation products. The Act was designed to protect the public from the dangers of electronic product radiation. Devices that either intentionally emit radiation (such as x-ray equipment) or emit radiation as a consequence of their opera­tion (such as CRTs and television sets) are covered. Further, certain light-emitting prod­ucts, which emit intense, directed radiation, such as lasers, t3 sunlamps, and ultraviolet lighting74 are also covered. In addition to specific emissions standards, and to prevent unnecessary exposure to such radiation due to the use of these products,75 manufacturers and distributors of products meeting the definition of electronic product radiation7 6 are required to comply with certain formalities, for example, record keeping, specific labeling requirements, and reporting to the Center for Devices and Radiological Health (CDRH).