21 C.F.R. § 1003.2 Defect in an electronic product.
Title 21 - Food and Drugs
For the purpose of this part, an electronic product shall be considered to have a defect which relates to the safety of use by reason of the emission of electronic product radiation if: (a) It is a product which does not utilize the emission of electronic product radiation in order to accomplish its purpose, and from which such emissions are unintended, and as a result of its design, production or assembly; (1) It emits electronic product radiation which creates a risk of injury, including genetic injury, to any person, or (2) It fails to conform to its design specifications relating to electronic radiation emissions; or (b) It is a product which utilizes electronic product radiation to accomplish its primary purpose and from which such emissions are intended, and as a result of its design, production or assembly it; (1) Fails to conform to its design specifications relating to the emission of electronic product radiation; or (2) Without regard to the design specifications of the product, emits electronic product radiation unnecessary to the accomplishment of its primary purpose which creates a risk of injury, including genetic injury to any person; or (3) Fails to accomplish the intended purpose.
Title 21: Food and Drugs
PART 1003—NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
Subpart A—General Provisions
§ 1003.2 Defect in an electronic product.