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Code · U.S. Code · Title 21 - FOOD AND DRUGS · CHAPTER 9— FEDERAL FOOD, DRUG, AND COSMETIC ACT · SUBCHAPTER V— DRUGS AND DEVICES · § 360oo

§ 360oo. Prohibited acts

563 words·~3 min read·/usc/title-21/section-360oo

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(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.
(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.)
Connections3 cite this · traces to 3
16 references not yet in our index
  • June 25, 1938, ch. 675, § 538
  • act July 1, 1944, ch. 373, title III, § 538
  • Pub. L. 90–602, § 2(3)
  • 82 Stat. 1184
  • Pub. L. 101–629, § 19(a)(1)(B)
  • 104 Stat. 4529
  • Pub. L. 103–80, § 4(a)(2)
  • 107 Stat. 779
  • section 263j of Title 42
  • Pub. L. 101–629
  • Pub. L. 103–80
  • Pub. L. 101–629, § 19(a)(4)
  • Pub. L. 101–629, § 19(a)(2)(F)(i)
  • Pub. L. 101–629, § 19(a)(2)(F)(ii)
  • Pub. L. 101–629, § 19(a)(2)(F)(iii)
  • section 4 of Pub. L. 90–602
Citation graph
cites case law
§ 360oo
Prohibited acts
Fed. Reg.×3
ActJune 25, 1938, ch. 675, § 538
Actact July 1, 1944, ch. 373, title III, § 538
Pub. L.Pub. L. 90–602, § 2(3)
Stat.82 Stat. 1184
Pub. L.Pub. L. 101–629, § 19(a)(1)(B)
Cites 19 · showing 8Cited by 3 across 1 source
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