21 U.S.C. § 360ll — Notification of defects in and repair or replacement of electronic products

submitted 88 years ago by Pub. L. 90-602 to r/title-21-FOOD-AND-DRUGS · 1,143 words · no verdicts yet

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Makers of electronic products must tell the FDA about safety defects or standards violations. They must also notify buyers and dealers, unless the FDA grants an exemption. If a product has a defect, the maker must fix it, replace it, or refund the buyer.

(a) Notification; exemption (1) If a manufacturer discovers that a product it made, assembled, or imported has a safety defect caused by radiation emission, or fails to meet a radiation standard set under section 360kk, it must immediately tell the FDA — if the product has already left the factory. The manufacturer must also promptly notify the people listed in subsection (b) (when it knows who they are), unless it gets an exemption under paragraph (2). (2) If the manufacturer believes the defect or violation isn't serious enough to risk injury (including genetic injury) to anyone, it can ask the FDA, when reporting the problem, for an exemption from notifying those people. It must give reasonable grounds and gets a chance to present evidence, carrying the burden of proof. If the FDA agrees the risk isn't significant, it will exempt the manufacturer both from notifying buyers and from the repair/replace/refund duties in subsection (f). (b) Method of notification Notice to people other than the FDA must go: (1) by certified mail to the first buyer (not for resale) and any later owner; and (2) by certified mail or a faster method to the manufacturer's dealers and distributors. (c) Requisite elements of notification The notice must clearly describe the defect or violation, evaluate the related hazard, and explain what will be done to fix it. Notices sent to buyers must also explain their rights under subsection (f). (d) Copies to Secretary of communications by manufacturers to dealers or distributors regarding defects Manufacturers must send the FDA a copy of every notice or bulletin they send dealers, distributors, or buyers about a defect or standards violation. The FDA can make some of this public if it helps carry out the law's purpose, but cannot disclose trade secrets or other protected information unless necessary for that purpose. (e) Notice from Secretary to manufacturer of defects or failure to comply with standards If the FDA — through its own testing, inspections, investigations, research, or reports it receives — finds that a product doesn't meet a radiation standard or has a safety defect, it must immediately tell the manufacturer, including its findings and the supporting evidence. The manufacturer gets a chance to respond and show there's no violation or defect. If the FDA still finds a violation or defect afterward, it will direct the manufacturer to send the required notice to buyers, dealers, and distributors — unless the manufacturer already received the "not significant risk" exemption described above. (f) Correction of defects If a product is found (under subsection (a) or (e)) to violate a standard or have a safety defect requiring notice, the manufacturer must, as the FDA directs by regulation: (1) fix the product for free and repay any shipping costs tied to the repair; (2) replace it with an equivalent product meeting all standards with no safety defect; or (3) refund its cost. (g) Effective date This section doesn't apply to any electronic product made before October 18, 1968.

the actual law source: uscode.house.gov ↗public domain

(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). 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.

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) 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.

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.)

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 90-602 · 82 Stat. 1180
1990Amended · Pub. L. 101-629 · 104 Stat. 4529, 4530
1993Amended · Pub. L. 103-80 · 107 Stat. 779

A history note hasn’t been published yet. The record shows enactment by Pub. L. 90-602 on 1938-06-25.

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