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21 U.S.C. § 360ll — Notification of defects in and repair or replacement of electronic products
Federal law — U.S. Code and appendices · legal_authorities
**(a) Notification; exemption**
(1) Every manufacturer of electronic products who discovers that an electronic product produced, assembled, or imported by him has a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation, or that an electronic product produced, assembled, or imported by him on or after the effective date of an applicable standard prescribed pursuant to [section 360kk of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk&num=0&edition=prelim) fails to comply with such standard, shall immediately notify the Secretary of such defect or failure to comply if such product has left the place of manufacture and shall (except as authorized by paragraph (2)) with reasonable promptness furnish notification of such defect or failure to the persons (where known to the manufacturer) specified in subsection (b) of this section.
(2) If, in the opinion of such manufacturer, the defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any person, he may, at the time of giving notice to the Secretary of such defect or failure to comply, apply to the Secretary for an exemption from the requirement of notice to the persons specified in subsection (b). If such application states reasonable grounds for such exemption, the Secretary shall afford such manufacturer an opportunity to present his views and evidence in support of the application, the burden of proof being on the manufacturer. If, after such presentation, the Secretary 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, he shall exempt such manufacturer from the req
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Source file: Laws/federal/codes/united-states-code/title-21/section-360ll-notification-of-defects-in-and-repair-or-replacement-of-electronic-produ--4089bd579f.md
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Source location: Title 21, Chapter 9, § 360ll; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) Notification; exemption**
(1) Every manufacturer of electronic products who discovers that an electronic product produced, assembled, or imported by him has a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation, or that an electronic product produced, assembled, or imported by him on or after the effective date of an applicable standard prescribed pursuant to [section 360kk of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk&num=0&edition=prelim) fails to comply with such standard, shall immediately notify the Secretary of such defect or failure to comply if such product has left the place of manufacture and shall (except as authorized by paragraph (2)) with reasonable promptness furnish notification of such defect or failure to the persons (where known to the manufacturer) specified in subsection (b) of this section.
(2) If, in the opinion of such manufacturer, the defect or failure to comply is not such as to create a significant risk of injury, including genetic injury, to any person, he may, at the time of giving notice to the Secretary of such defect or failure to comply, apply to the Secretary for an exemption from the requirement of notice to the persons specified in subsection (b). If such application states reasonable grounds for such exemption, the Secretary shall afford such manufacturer an opportunity to present his views and evidence in support of the application, the burden of proof being on the manufacturer. If, after such presentation, the Secretary 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, he shall exempt such manufacturer from the requirement of notice to the persons specified in subsection (b) of this section and from the requirements of repair or replacement imposed by subsection (f) of this section.
**(b) Method of notification** The notification (other than to the Secretary) required by paragraph (1) of subsection (a) of this section shall be accomplished—
(1) by certified mail to the first purchaser of such product for purposes other than resale, and to any subsequent transferee of such product; and
(2) by certified mail or other more expeditious means to the dealers or distributors of such manufacturer to whom such product was delivered.
**(c) Requisite elements of notification** 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.
**(d) Copies to Secretary of communications by manufacturers to dealers or distributors regarding defects** 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360nn&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title18-section1905&num=0&edition=prelim) 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360nn&num=0&edition=prelim), or otherwise, the Secretary determines that any electronic product—
(1) does not comply with an applicable standard prescribed pursuant to [section 360kk of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk&num=0&edition=prelim); or
(2) contains a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation;
he shall immediately notify the manufacturer of such product of such defect or failure to comply. The notice shall contain the findings of the Secretary and shall include all information upon which the findings are based. The Secretary shall afford such manufacturer 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 by reason of the emission of such radiation hazard. If after such presentation by the manufacturer the Secretary determines that such product does not comply with an applicable standard prescribed pursuant to [section 360kk of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk&num=0&edition=prelim), or that it contains a defect which relates to the safety of use of such product by reason of the emission of electronic product radiation, the Secretary shall direct the manufacturer to furnish the notification specified in subsection (c) of this section to the persons specified in paragraphs (1) and (2) of subsection (b) of this section (where known to the manufacturer), unless the manufacturer has applied for an exemption from the requirement of such notification on the ground specified in paragraph (2) of subsection (a) and the Secretary is satisfied that such noncompliance or defect is not such as to create a significant risk of injury, including genetic injury, to any person.
**(f) Correction of defects** 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.
**(g) Effective date** This section shall not apply to any electronic product that was manufactured before October 18, 1968.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Promulgation of regulations**
(1) The Secretary shall by regulation prescribe performance standards for electronic products to control the emission of electronic product radiation from such products if he determines that such standards are necessary for the protection of the public health and safety. Such standards may include provisions for the testing of such products and the measurement of their electronic product radiation emissions, may require the attachment of warning signs and labels, and may require the provision of instructions for the installation, operation, and use of such products. Such standards may be prescribed from time to time whenever such determinations are made, but the first of such standards shall be prescribed prior to January 1, 1970. In the development of such standards, the Secretary shall consult with Federal and State departments and agencies having related responsibilities or interests and with appropriate professional organizations and interested persons, including representatives of industries and labor organizations which would be affected by such standards, and shall give consideration to—
(A) the latest available scientific and medical data in the field of electronic product radiation;
(B) the standards currently recommended by (i) other Federal agencies having responsibilities relating to the control and measurement of electronic product radiation, and (ii) public or private groups having an expertise in the field of electronic product radiation;
(C) the reasonableness and technical feasibility of such standards as applied to a particular electronic product;
(D) the adaptability of such standards to the need for uniformity and reliability of testing and measuring procedures and equipment; and
(E) in the case of
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360kk
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Federal law — U.S. Code and appendices · legal_authorities
Whoever, being an officer or employee of the United States or of any department or agency thereof, any person acting on behalf of the Federal Housing Finance Agency, or agent of the Department of Justice as defined in the Antitrust Civil Process Act ([15 U.S.C. 1311–131](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title15-section1311–131&num=0&edition=prelim)4), or being an employee of a private sector organization who is or was assigned to an agency under chapter 37 of title 5, publishes, divulges, discloses, or makes known in any manner or to any extent not authorized by law any information coming to him in the course of his employment or official duties or by reason of any examination or investigation made by, or return, report or record made to or filed with, such department or agency or officer or employee thereof, which information concerns or relates to the trade secrets, processes, operations, style of work, or apparatus, or to the identity, confidential statistical data, amount or source of any income, profits, losses, or expenditures of any person, firm, partnership, corporation, or association; or permits any income return or copy thereof or any book containing any abstract or particulars thereof to be seen or examined by any person except as provided by law; shall be fined under this title, or imprisoned not more than one year, or both; and shall be removed from office or employment.
Source: Supplied U.S. Code snapshot — release unconfirmed · 18 U.S.C. § 1905
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Inspection of premises** If the Secretary finds for good cause that the methods, tests, or programs related to electronic product radiation safety in a particular factory, warehouse, or establishment in which electronic products are manufactured or held, may not be adequate or reliable, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are thereafter authorized (1) to enter, at reasonable times, any area in such factory, warehouse, or establishment in which the manufacturer’s tests (or testing programs) required by [section 360kk(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360kk/h&num=0&edition=prelim) are carried out, and (2) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, the facilities and procedures within such area which are related to electronic product radiation safety. Each such inspection shall be commenced and completed with reasonable promptness. In addition to other grounds upon which good cause may be found for purposes of this subsection, good cause will be considered to exist in any case where the manufacturer has introduced into commerce any electronic product which does not comply with an applicable standard prescribed under this part and with respect to which no exemption from the notification requirements has been granted by the Secretary under section 360ll(a)(2) or 360ll(e) of this title.
**(b) Record keeping** Every manufacturer of electronic products shall establish and maintain such records (including testing records), make such reports, and provide such information, as the Secretary may reasonably require to enable him to determine whether
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360nn
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Federal law — U.S. Code and appendices · legal_authorities
As used in this part—
(1) the term “electronic product radiation” means—
(A) any ionizing or non-ionizing electromagnetic or particulate radiation, or
(B) any sonic, infrasonic, or ultrasonic wave, which is emitted from an electronic product as the result of the operation of an electronic circuit in such product;
(2) the term “electronic product” means (A) any manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (B) any manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation;
(3) the term “manufacturer” means any person engaged in the business of manufacturing, assembling, or importing of electronic products;
(4) the term “commerce” means (A) commerce between any place in any State and any place outside thereof; and (B) commerce wholly within the District of Columbia; and
(5) the term “State” includes the District of Columbia, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the Virgin Islands, Guam, and American Samoa.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360hh
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Federal law — U.S. Code and appendices · legal_authorities
Page 408
TITLE 21—FOOD AND DRUGS
§ 360ll
States pursuant to subsection (c) of section 210
of title 42 shall not render members of the Com-
mittee officers or employees of the United
States for any purpose.
(g) Review and evaluation
The Secretary shall review and evaluate on a
continuing basis testing programs carried out
by industry to assure the adequacy of safeguards
against hazardous electronic product radiation
and to assure that electronic products comply
with standards prescribed under this section.
(h) Product certification
Every manufacturer of an electronic product
to which is applicable a standard in effect under
this section shall furnish to the distributor or
dealer at the time of delivery of such product, in
the form of a label or tag permanently affixed to
such product or in such manner as approved by
the Secretary, the certification that such prod-
uct conforms to all applicable standards under
this section. Such certification shall be based
upon a test, in accordance with such standard,
of the individual article to which it is attached
or upon a testing program which is in accord
with good manufacturing practice and which has
not been disapproved by the Secretary (in such
manner as he shall prescribe by regulation) on
the grounds that it does not assure the adequacy
of safeguards against hazardous electronic prod-
uct radiation or that it does not assure that
electronic products comply with the standards
prescribed under this section.
(June 25, 1938, ch. 675, § 534, formerly act July 1,
1944, ch. 373, title III, § 534, formerly § 358, as
added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat.
1177; amended Pub. L. 91–515, title VI, § 601(b)(2),
(3), Oct. 30, 1970, 84 Stat. 1311; renumbered § 534
and amended Pub. L. 101–62
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 360ll
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