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21CFR1003.2

§ 1003.2 Defect in an electronic product.

Regulation Text

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; (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) 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 (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.

Authority

21 U.S.C. 360hh-360ss.

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Related Guidelines (4)

21CFR1003.2 — § 1003.2 Defect in an electronic product. | CFR Explorer | BioRegHub