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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2019]
[CITE: 21CFR1005]





TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER J--RADIOLOGICAL HEALTH
 
PART 1005IMPORTATION OF ELECTRONIC PRODUCTS
 

Subpart A--General Provisions

Sec. 1005.1 Applicability.

(a) The provisions of 1005.1 through 1005.24 are applicable to electronic products which are subject to the standards prescribed under this subchapter and are offered for importation into the United States.

(b) Section 1005.25 is applicable to every manufacturer of electronic products offering an electronic product for importation into the United States.

[38 FR 28630, Oct. 15, 1973, as amended at 45 FR 81739, Dec. 12, 1980]

Sec. 1005.2 Definitions.

As used in this part:

The term owner or consignee means the person who makes entry under the provisions of section 484 of the Tariff Act of 1930, as amended (19 U.S.C. 1484), namely, the "importer of record."

[81 FR 85973, Nov. 29, 2016]

Sec. 1005.3 Importation of noncomplying goods prohibited.

The importation of any electronic product for which standards have been prescribed under section 534 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360kk) shall be refused admission into the United States unless there is affixed to such product a certification in the form of a label or tag in conformity with section 534(h) of the act (21 U.S.C. 360kk(h)). Merchandise refused admission shall be destroyed or exported under regulations prescribed by the Secretary of the Treasury unless a timely and adequate petition for permission to bring the product into compliance is filed and granted under 1005.21 and 1005.22.

[69 FR 11314, Mar. 10, 2004]

Authority: 21 U.S.C. 360ii, 360mm.
Source: 38 FR 28630, Oct. 15, 1973, unless otherwise noted.

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