Manufacturers and distributors of products meeting the definition of “electronic product radiation” in Section 531 of the FDCA may be subject to certain provisions of the Act including the retention of records and submission of product reports to the FDA, specifically to the Center for Devices and Radiological Health (CDRH). The FDA requirements for these products, record keeping and reporting, are included in the final regulations contained in Title 21 Code of Federal Regulations Parts 1000-1299. According to Section 531 of the FD&C Act:
(1) the term “electronic product radiation” means—
(A) any ionizing or nonionizing electromagnetic or particulate radiation, or
(B) 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;
(2) the term “electronic product” means—
(A) any manufactured or assembled product which, when in operation,
(i) contains or acts as part of an electronic circuit and
(ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or
(B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in Clause (A) and which, when in operation, emits (or in the absence of effective shielding or other controls would emit) such radiation;
(i) the term “manufacturer” means any person engaged in the business of manufacturing, assembling, or importing of electronic products.
Most radiation-emitting products are not considered to be medical devices. However, if you make any medical claims, your product is a medical device subject to the provisions of the FDCA for medical devices in addition to the provisions for radiation emitting products. Examples of electronic products:
Medical: diagnostic x-ray or ultrasound imaging devices, microwave or ultrasound diathermy devices, microwave blood warmers or sterilizers, laser coagulators, ultrasound phacoemulsifiers, x-ray or electron accelerators, sunlamps, ultraviolet dental curing devices;
Nonmedical: microwave ovens, televisions receivers and monitors (video displays), entertainment lasers, industrial x-ray systems, cordless and cellular telephones, industrial RF sealers of plastics and laminates, laser CD players.