21 U.S. Code § -

(a) It shall be unlawful—
(1) for any manufacturer to introduce, or to deliver for introduction, into commerce, or to import into the United States, any electronic product which does not comply with an applicable standard prescribed pursuant to section 360kk of this title;
(2) for any person to fail to furnish any notification or other material or information required by section 360ll or 360nn of this title; or to fail to comply with the requirements of section 360ll (f) of this title;
(3) for any person to fail or to refuse to establish or maintain records required by this part or to permit access by the Secretary or any of his duly authorized representatives to, or the copying of, such records, or to permit entry or inspection, as required by or pursuant to section 360nn of this title;
(4) for any person to fail or to refuse to make any report required pursuant to section 360nn (b) of this title or to furnish or preserve any information required pursuant to section 360nn (f) of this title; or
(5) for any person
(A) to fail to issue a certification as required by section 360kk (h) of this title, or
(B) to issue such a certification when such certification is not based upon a test or testing program meeting the requirements of section 360kk (h) of this title or when the issuer, in the exercise of due care, would have reason to know that such certification is false or misleading in a material respect.
(b) The Secretary may exempt any electronic product, or class thereof, from all or part of subsection (a) of this section, upon such conditions as he may find necessary to protect the public health or welfare, for the purpose of research, investigations, studies, demonstrations, or training, or for reasons of national security.

Source

(June 25, 1938, ch. 675, § 538, formerly act July 1, 1944, ch. 373, title III, § 538, formerly § 360B, as added Pub. L. 90–602, § 2(3),Oct. 18, 1968, 82 Stat. 1184; renumbered § 538 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(F), (3), (4),Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2),Aug. 13, 1993, 107 Stat. 779.)
Codification

Section was classified to section 263j 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 263j of Title 42, The Public Health and Welfare, as this section.
1990—Subsec. (a)(1). Pub. L. 101–629, § 19(a)(2)(F)(i), substituted “section 360kk” for “section 263f”.
Subsec. (a)(2). Pub. L. 101–629, § 19(a)(2)(F)(ii), (iii), substituted “section 360ll or 360nn” for “section 263g or 263i” and “section 360ll (f)” for “section 263g(f)”.
Subsec. (a)(3). Pub. L. 101–629, § 19(a)(1)(B), (2)(F)(iii), substituted “this part” for “this subpart” and “section 360nn” for “section 263i”.
Subsec. (a)(4). Pub. L. 101–629, § 19(a)(2)(F)(iii), substituted “section 360nn (b)” for “section 263i(b)” and “section 360nn (f)” for “section 263i(f)”.
Subsec. (a)(5). Pub. L. 101–629, § 19(a)(2)(F)(i), substituted “section 360kk (h)” for “section 263f(h)” 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].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


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 1010 - PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

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

 

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