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Code · CFR · Title 21 — Food and Drugs · Part 1003 — Notification of Defects or Failure to Comply · § 1003.2

§ 1003.2. Defect in an electronic product.

197 words·~1 min read·/us/cfr/t21/s§ 1003.2

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

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.
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