CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR1003.2]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER J - RADIOLOGICAL HEALTH

PART 1003 -- NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY

Subpart A - General Provisions

Sec. 1003.2 Defect in an electronic product.

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.