21 U.S.C. § 360oo: Prohibited acts

Summary

It is illegal for anyone to sell or bring into the United States an electronic product that does not meet the safety standard made under section 360kk. It is also illegal to fail to give required notices, papers, or information under sections 360ll or 360nn, to refuse to keep required records or let the Secretary or their agents inspect or copy those records, or to fail to make required reports or keep required information under section 360nn. Makers must also give any required certification based on the proper tests and must not give a certification they would know is false or misleading. The Secretary may excuse a product or group of products from some or all of these rules when needed to protect public health or welfare, for research or training, or for national security.

Title 21, §360oo

Food and Drugs, Source: USLM XML via OLRC

(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), 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.

Notes & Related Subsidiaries

Editorial Notes

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. 103–80 amended 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.

Statutory Notes and Related Subsidiaries

Noninterference With Other Federal AgenciesEnactment 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 of Pub. L. 90–602, set out as a note under section 360hh of this title.

§360oo Prohibited Acts