The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulate the manufacture of radiation emitting electronic products. The CDRH is an organizational component of the FDA that has been given the legal authority to regulate these products under the United States Federal, Food, Drug and Cosmetic (FD&C) Act, Chapter V, Subchapter C, Electronic Product Radiation Control.
The purpose of the FD&C Act is to protect the public from hazardous and unnecessary exposure to radiation from electronic products. There are general requirements that apply to all radiation emitting electronic products and additional requirements specific to certain types of products. If the product is also a medical device, the product must also comply with the medical device regulations.
Any product that contains an electronic circuit and generates any kind of radiation is an electronic product that emits radiation. Lasers are just one type of electronic product that emits radiation. Manufacturers. distributors, and importers of laser products may be subject to certain requirements created under the FD&C Act.. The Food and Drug Administration (FDA) requirements for these products, including requirements for record keeping and reporting, are included in the final regulations contained in T