---
kind: "section"
citation: "21 U.S.C. § 360oo"
title: "21"
title_heading: "Food and Drugs"
number: "360oo"
heading: "Prohibited acts"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360oo"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part C — Electronic Product Radiation Control"
---

# §360oo. Prohibited acts

- (a) It shall be unlawful—
  - (1) for any [manufacturer](/usc/21/360hh.md?p=3) to introduce, or to deliver for introduction, into [commerce](/usc/21/360hh.md?p=4), or to import into the United States, any [electronic product](/usc/21/360hh.md?p=2) which does not comply with an applicable standard prescribed pursuant to [section 360kk of this title](/usc/21/360kk.md);
  - (2) for any [person](/usc/21/321.md?p=e) to fail to furnish any notification or other material or information required by section [360ll](/usc/21/360ll.md) or [360nn](/usc/21/360nn.md) of this title; or to fail to comply with the requirements of [section 360ll(f)](/usc/21/360ll.md?p=f) of this title;
  - (3) for any [person](/usc/21/321.md?p=e) to fail or to refuse to establish or maintain records required by this part or to permit access by the [Secretary](/usc/21/321.md?p=d) or any of his duly [authorized](/usc/21/360eee.md?p=2) 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](/usc/21/360nn.md);
  - (4) for any [person](/usc/21/321.md?p=e) to fail or to refuse to make any report required pursuant to [section 360nn(b) of this title](/usc/21/360nn.md?p=b) or to furnish or preserve any information required pursuant to [section 360nn(f) of this title](/usc/21/360nn.md?p=f); or
  - (5) for any [person](/usc/21/321.md?p=e) (A) to fail to issue a certification as required by [section 360kk(h) of this title](/usc/21/360kk.md?p=h), 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](/usc/21/360kk.md?p=h) 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](/usc/21/321.md?p=d) may exempt any [electronic product](/usc/21/360hh.md?p=2), or class thereof, from all or part of [subsection (a)](#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.

## Source credit

(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.)

## Notes

### 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 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 of Pub. L. 90–602, set out as a note under section 360hh of this title.
