---
kind: "section"
citation: "21 U.S.C. § 360ll"
title: "21"
title_heading: "Food and Drugs"
number: "360ll"
heading: "Notification of defects in and repair or replacement of electronic products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360ll"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part C — Electronic Product Radiation Control"
---

# §360ll. Notification of defects in and repair or replacement of electronic products

- (a) **Notification; exemption—**
  - (1) Every [manufacturer](/usc/21/360hh.md?p=3) of [electronic products](/usc/21/360hh.md?p=2) who discovers that an [electronic product](/usc/21/360hh.md?p=2) produced, assembled, or imported by him has a defect which relates to the safety of use of such [product](/usc/21/360eee.md?p=13) by reason of the emission of [electronic product radiation](/usc/21/360hh.md?p=1), or that an [electronic product](/usc/21/360hh.md?p=2) produced, assembled, or imported by him on or after the effective date of an applicable standard prescribed pursuant to [section 360kk of this title](/usc/21/360kk.md) fails to comply with such standard, shall immediately notify the [Secretary](/usc/21/321.md?p=d) of such defect or failure to comply if such [product](/usc/21/360eee.md?p=13) has left the place of manufacture and shall (except as [authorized](/usc/21/360eee.md?p=2) by [paragraph (2)](#a-2)) with reasonable promptness furnish notification of such defect or failure to the [persons](/usc/21/321.md?p=e) (where known to the [manufacturer](/usc/21/360hh.md?p=3)) specified in [subsection (b)](#b) of this section.
  - (2) If, in the opinion of such [manufacturer](/usc/21/360hh.md?p=3), the defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any [person](/usc/21/321.md?p=e), he may, at the time of giving notice to the [Secretary](/usc/21/321.md?p=d) of such defect or failure to comply, apply to the [Secretary](/usc/21/321.md?p=d) for an exemption from the requirement of notice to the [persons](/usc/21/321.md?p=e) specified in [subsection (b)](#b). If such application [states](/usc/21/321.md?p=a-1) reasonable grounds for such exemption, the [Secretary](/usc/21/321.md?p=d) shall afford such [manufacturer](/usc/21/360hh.md?p=3) an opportunity to present his views and evidence in support of the application, the burden of proof being on the [manufacturer](/usc/21/360hh.md?p=3). If, after such presentation, the [Secretary](/usc/21/321.md?p=d) is satisfied that such defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any [person](/usc/21/321.md?p=e), he shall exempt such [manufacturer](/usc/21/360hh.md?p=3) from the requirement of notice to the [persons](/usc/21/321.md?p=e) specified in [subsection (b)](#b) of this section and from the requirements of repair or replacement imposed by [subsection (f)](#f) of this section.
- (b) **Method of notification—** The notification (other than to the [Secretary](/usc/21/321.md?p=d)) required by [paragraph (1)](#a-1) of subsection (a) of this section shall be accomplished—
  - (1) by certified mail to the first purchaser of such [product](/usc/21/360eee.md?p=13) for purposes other than resale, and to any subsequent transferee of such [product](/usc/21/360eee.md?p=13); and
  - (2) by certified mail or other more expeditious means to the dealers or distributors of such [manufacturer](/usc/21/360hh.md?p=3) to whom such [product](/usc/21/360eee.md?p=13) was delivered.
- (c) **Requisite elements of notification—** The notifications required by [paragraph (1)](#a-1) of subsection (a) of this section shall contain a clear description of such defect or failure to comply with an applicable standard, an evaluation of the hazard reasonably related to such defect or failure to comply, and a statement of the measures to be taken to repair such defect. In the case of a notification to a [person](/usc/21/321.md?p=e) referred to in [subsection (b)](#b) of this section, the notification shall also advise the [person](/usc/21/321.md?p=e) of his rights under [subsection (f)](#f) of this section.
- (d) **Copies to Secretary of communications by manufacturers to dealers or distributors regarding defects—** Every [manufacturer](/usc/21/360hh.md?p=3) of [electronic products](/usc/21/360hh.md?p=2) shall furnish to the [Secretary](/usc/21/321.md?p=d) a true or representative copy of all notices, bulletins, and other communications to the dealers or distributors of such [manufacturer](/usc/21/360hh.md?p=3) or to purchasers (or subsequent transferees) of [electronic products](/usc/21/360hh.md?p=2) of such [manufacturer](/usc/21/360hh.md?p=3) regarding any such defect in such [product](/usc/21/360eee.md?p=13) or any such failure to comply with a standard applicable to such [product](/usc/21/360eee.md?p=13). The [Secretary](/usc/21/321.md?p=d) shall disclose to the public so much of the information contained in such notice or other information obtained under [section 360nn of this title](/usc/21/360nn.md) as he deems will assist in carrying out the purposes of this part, but he shall not disclose any information which contains or relates to a trade secret or other matter referred to in [section 1905 of title 18](/usc/18/1905.md) unless he determines that it is necessary to carry out the purposes of this part.
- (e) **Notice from Secretary to manufacturer of defects or failure to comply with standards—** If through testing, inspection, investigation, or research carried out pursuant to this part, or examination of reports submitted pursuant to [section 360nn of this title](/usc/21/360nn.md), or otherwise, the [Secretary](/usc/21/321.md?p=d) determines that any [electronic product](/usc/21/360hh.md?p=2)—
  - (1) does not comply with an applicable standard prescribed pursuant to [section 360kk of this title](/usc/21/360kk.md); or
  - (2) contains a defect which relates to the safety of use of such [product](/usc/21/360eee.md?p=13) by reason of the emission of [electronic product radiation](/usc/21/360hh.md?p=1);

  he shall immediately notify the [manufacturer](/usc/21/360hh.md?p=3) of such [product](/usc/21/360eee.md?p=13) of such defect or failure to comply. The notice shall contain the findings of the [Secretary](/usc/21/321.md?p=d) and shall include all information upon which the findings are based. The [Secretary](/usc/21/321.md?p=d) shall afford such [manufacturer](/usc/21/360hh.md?p=3) an opportunity to present his views and evidence in support thereof, to establish that there is no failure of compliance or that the alleged defect does not exist or does not relate to safety of use of the [product](/usc/21/360eee.md?p=13) by reason of the emission of such radiation hazard. If after such presentation by the [manufacturer](/usc/21/360hh.md?p=3) the [Secretary](/usc/21/321.md?p=d) determines that such [product](/usc/21/360eee.md?p=13) does not comply with an applicable standard prescribed pursuant to [section 360kk of this title](/usc/21/360kk.md), or that it contains a defect which relates to the safety of use of such [product](/usc/21/360eee.md?p=13) by reason of the emission of [electronic product radiation](/usc/21/360hh.md?p=1), the [Secretary](/usc/21/321.md?p=d) shall direct the [manufacturer](/usc/21/360hh.md?p=3) to furnish the notification specified in [subsection (c)](#c) of this section to the [persons](/usc/21/321.md?p=e) specified in paragraphs [(1)](#b-1) and [(2)](#b-2) of subsection (b) of this section (where known to the [manufacturer](/usc/21/360hh.md?p=3)), unless the [manufacturer](/usc/21/360hh.md?p=3) has applied for an exemption from the requirement of such notification on the ground specified in [paragraph (2)](#a-2) of subsection (a) and the [Secretary](/usc/21/321.md?p=d) is satisfied that such noncompliance or defect is not such as to create a significant risk of injury, including genetic injury, to any [person](/usc/21/321.md?p=e).

- (f) **Correction of defects—** If any [electronic product](/usc/21/360hh.md?p=2) is found under subsection [(a)](#a) or [(e)](#e) to fail to comply with an applicable standard prescribed under this part or to have a defect which relates to the safety of use of such [product](/usc/21/360eee.md?p=13), and the notification specified in [subsection (c)](#c) is required to be furnished on account of such failure or defect, the [manufacturer](/usc/21/360hh.md?p=3) of such [product](/usc/21/360eee.md?p=13) shall (1) without charge, bring such [product](/usc/21/360eee.md?p=13) into conformity with such standard or remedy such defect and provide reimbursement for any expenses for transportation of such [product](/usc/21/360eee.md?p=13) incurred in connection with having such [product](/usc/21/360eee.md?p=13) brought into conformity or having such defect remedied, (2) replace such [product](/usc/21/360eee.md?p=13) with a like or equivalent [product](/usc/21/360eee.md?p=13) which complies with each applicable standard prescribed under this part and which has no defect relating to the safety of its use, or (3) make a refund of the cost of such [product](/usc/21/360eee.md?p=13). The [manufacturer](/usc/21/360hh.md?p=3) shall take the action required by this subsection in such manner, and with respect to such [persons](/usc/21/321.md?p=e), as the [Secretary](/usc/21/321.md?p=d) by regulations shall prescribe.
- (g) **Effective date—** This section shall not apply to any [electronic product](/usc/21/360hh.md?p=2) that was manufactured before October 18, 1968.

## Source credit

(June 25, 1938, ch. 675, § 535, formerly act July 1, 1944, ch. 373, title III, § 535, formerly § 359, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1180; renumbered § 535 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(C), (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 263g 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 263g of Title 42, The Public Health and Welfare, as this section.

1990—Subsec. (a)(1). Pub. L. 101–629, § 19(a)(2)(C)(i), substituted “section 360kk” for “section 263f”.

Subsec. (d). Pub. L. 101–629, § 19(a)(1)(B), (2)(C)(ii), substituted “section 360nn” for “section 263i” and “this part” for “this subpart” in two places.

Subsec. (e). Pub. L. 101–629, § 19(a)(1)(B), (2)(C), substituted “this part” for “this subpart” and “section 360nn” for “section 263i” in introductory provisions and “section 360kk” for “section 263f” in par. (1) and concluding provisions.

Subsec. (f). Pub. L. 101–629, § 19(a)(1)(B), substituted “this part” for “this subpart” 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.