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21 U.S.C. § 360ll

Notification of defects in and repair or replacement of electronic products

United States · Title 21 — FOOD AND DRUGS · Status: effective

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21 U.S.C. § 360ll, Notification of defects in and repair or replacement of electronic products, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/454304
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The notification (other than to the Secretary) required by paragraph (1) of subsection (a) of this section shall be accomplished— The notifications required by paragraph (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 referred to in subsection (b) of this section, the notification shall also advise the person of his rights under subsection (f) of this section. Every manufacturer of electronic products shall furnish to the Secretary a true or representative copy of all notices, bulletins, and other communications to the dealers or distributors of such manufacturer or to purchasers (or subsequent transferees) of electronic products of such manufacturer regarding any such defect in such product or any such failure to comply with a standard applicable to such product. The Secretary shall disclose to the public so much of the information contained in such notice or other information obtained under section 360nn of this title 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 unless he determines that it is necessary to carry out the purposes of this part. 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, or otherwise, the Secretary determines that any electronic product— If any electronic product is found under subsection (a) or (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, and the notification specified in subsection (c) is required to be furnished on account of such failure or defect, the manufacturer of such product shall (1) without charge, bring such product into conformity with such standard or remedy such defect and provide reimbursement for any expenses for transportation of such product incurred in connection with having such product brought into conformity or having such defect remedied, (2) replace such product with a like or equivalent product 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. The manufacturer shall take the action required by this subsection in such manner, and with respect to such persons, as the Secretary by regulations shall prescribe. This section shall not apply to any electronic product that was manufactured before October 18, 1968.

Legislative history

The public laws that enacted or amended this section. Tallies are for the whole bill as it passed each chamber — often an omnibus covering far more than this provision — not a vote on this section alone. The law that originally enacted this section predates the public laws loaded here, so only later amendments are listed.

  • Amended byPub. L. 101-629(H.R. 3095)1990-11-28
    Safe Medical Devices Act of 1990
    House: no recorded tallySenate: no recorded tally
  • Amended byPub. L. 103-80(H.R. 2900)1993-08-13
    Nutrition Labeling and Education Act Amendments of 1993
    House: no recorded tallySenate: no recorded tally