CFR - Code of Federal Regulations Title 21

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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]

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. 1003.1 Applicability.

The provisions of this part are applicable to electronic products which were manufactured after October 18, 1968.

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.

Sec. 1003.5 Effect of regulations on other laws.

The remedies provided for in this subchapter shall be in addition to and not in substitution for any other remedies provided by law and shall not relieve any person from liability at common law or under statutory law.

Authority: 21 U.S.C. 360hh-360ss.
Source: 38 FR 28628, Oct. 15, 1973, unless otherwise noted.