21 U.S. Code § 360mm - Imports

(a) Refusal of admission to noncomplying electronic products
Any electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed under this part, or to which is not affixed a certification in the form of a label or tag in conformity with section 360kk (h) of this title shall be refused admission into the United States. The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon the latter’s request, samples of electronic products which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may have a hearing before the Secretary of Health and Human Services. If it appears from an examination of such samples or otherwise that any electronic product fails to comply with applicable standards prescribed pursuant to section 360kk of this title, then, unless subsection (b) of this section applies and is complied with,
(1) such electronic product shall be refused admission, and
(2) the Secretary of the Treasury shall cause the destruction of such electronic product unless such article is exported, under regulations prescribed by the Secretary of the Treasury, within 90 days after the date of notice of refusal of admission or within such additional time as may be permitted by such regulations.
(b) Bond
If it appears to the Secretary of Health and Human Services that any electronic product refused admission pursuant to subsection (a) of this section can be brought into compliance with applicable standards prescribed pursuant to section 360kk of this title, final determination as to admission of such electronic product may be deferred upon filing of timely written application by the owner or consignee and the execution by him of a good and sufficient bond providing for the payment of such liquidated damages in the event of default as the Secretary of Health and Human Services may by regulation prescribe. If such application is filed and such bond is executed the Secretary of Health and Human Services may, in accordance with rules prescribed by him, permit the applicant to perform such operations with respect to such electronic product as may be specified in the notice of permission.
(c) Liability of owner or consignee for expenses connected with refusal of admission
All expenses (including travel, per diem or subsistence, and salaries of officers or employees of the United States) in connection with the destruction provided for in subsection (a) of this section and the supervision of operations provided for in subsection (b) of this section, and all expenses in connection with the storage, cartage, or labor with respect to any electronic product refused admission pursuant to subsection (a) of this section, shall be paid by the owner or consignee, and, in event of default, shall constitute a lien against any future importations made by such owner or consignee.
(d) Designation of agent for purposes of service
It shall be the duty of every manufacturer offering an electronic product for importation into the United States to designate in writing an agent upon whom service of all administrative and judicial processes, notices, orders, decisions, and requirements may be made for and on behalf of said manufacturer, and to file such designation with the Secretary, which designation may from time to time be changed by like writing, similarly filed. Service of all administrative and judicial processes, notices, orders, decisions, and requirements may be made upon said manufacturer by service upon such designated agent at his office or usual place of residence with like effect as if made personally upon said manufacturer, and in default of such designation of such agent, service of process, notice, order, requirement, or decision in any proceeding before the Secretary or in any judicial proceeding for enforcement of this part or any standards prescribed pursuant to this part may be made by posting such process, notice, order, requirement, or decision in the Office of the Secretary or in a place designated by him by regulation.

Source

(June 25, 1938, ch. 675, § 536, formerly act July 1, 1944, ch. 373, title III, § 536, formerly § 360, as added Pub. L. 90–602, § 2(3),Oct. 18, 1968, 82 Stat. 1181; renumbered § 536 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(D), (3), (4),Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 102–300, § 6(b)(1),June 16, 1992, 106 Stat. 240; Pub. L. 103–80, § 4(a)(2),Aug. 13, 1993, 107 Stat. 779.)
Codification

Section was classified to section 263h of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.
Amendments

1993—Pub. L. 103–80amended directory language of Pub. L. 101–629, § 19(a)(4), which renumbered section 263h of Title 42, The Public Health and Welfare, as this section.
1992—Subsecs. (a), (b). Pub. L. 102–300substituted “Health and Human Services” for “Health, Education, and Welfare” wherever appearing.
1990—Subsec. (a). Pub. L. 101–629, § 19(a)(1)(B), (2)(D), substituted “this part” for “this subpart”, “section 360kk (h)” for “section 263f(h)”, and “section 360kk” for “section 263f”.
Subsec. (b). Pub. L. 101–629, § 19(a)(2)(D), substituted “section 360kk” for “section 263f”.
Subsec. (d). Pub. L. 101–629, § 19(a)(1)(B), substituted “this part” for “this subpart” in two places.
Noninterference With Other Federal Agencies

Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 ofPub. L. 90–602, set out as a note under section 360hh of this title.

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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21 CFR - Food and Drugs

21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR Part 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES

21 CFR Part 1000 - GENERAL

21 CFR Part 1002 - RECORDS AND REPORTS

21 CFR Part 1003 - NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY

21 CFR Part 1004 - REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS

21 CFR Part 1005 - IMPORTATION OF ELECTRONIC PRODUCTS

21 CFR Part 1010 - PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

21 CFR Part 1020 - PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

 

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