
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC360ll]

 
                        TITLE 21--FOOD AND DRUGS
 
             CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
 
                     SUBCHAPTER V--DRUGS AND DEVICES
 
              Part C--Electronic Product Radiation Control
 
Sec. 360ll. Notification of defects in and repair or replacement 
        of electronic products
        

(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 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) of this section. 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 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.

(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, 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; 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, 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) of this section 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) of 
this section 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) of 
this section 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.

(June 25, 1938, ch. 675, Sec. 535, formerly act July 1, 1944, ch. 373, 
title III, Sec. 535, formerly Sec. 359, as added Pub. L. 90-602, 
Sec. 2(3), Oct. 18, 1968, 82 Stat. 1180; renumbered Sec. 535 and amended 
Pub. L. 101-629, Sec. 19(a)(1)(B), (2)(C), (3), (4), Nov. 28, 1990, 104 
Stat. 4529, 4530; Pub. L. 103-80, Sec. 4(a)(2), Aug. 13, 1993, 107 Stat. 
779.)

                          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, 
Sec. 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, Sec. 19(a)(2)(C)(i), 
substituted ``section 360kk'' for ``section 263f''.
    Subsec. (d). Pub. L. 101-629, Sec. 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, Sec. 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, Sec. 19(a)(1)(B), substituted ``this 
part'' for ``this subpart'' in two places.


               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.

                  Section Referred to in Other Sections

    This section is referred to in sections 360nn, 360oo of this title.
