21 CFR 1010.2

(a) Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the certification that such product conforms to all applicable standards under this subchapter.

(b) The certification shall be in the form of a label or tag permanently affixed to or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use, unless the applicable standard prescribes some other manner of certification. All such labels or tags shall be in the English language.

(c) Such certification shall be based upon a test, in accordance with the standard, of the individual article to which it is attached or upon a testing program which is in accordance with good manufacturing practices. The Director, Center for Devices and Radiological Health may disapprove such a testing program on the grounds that it does not assure the adequacy of safeguards against hazardous electronic product radiation or that it does not assure that electronic products comply with the standards prescribed under this subchapter.

(d) In the case of products for which it is not feasible to certify in accordance with paragraph (b) of this section, upon application by the manufacturer, the Director, Center for Devices and Radiological Health may approve an alternate means by which such certification may be provided.

(e) Laser products under § 1040.10 of this chapter that incorporate a certified laser system (laser product) will be considered to have met the certification requirements in this section if all of the following conditions are met:

(1) The incorporated laser system is not a laser product intended for use as a component or replacement as described in § 1040.10(a)(1) and (2) of this chapter;

(2) The manufacturer of the incorporated laser system has certified such laser system under this section and meets the reporting requirements under part 1002 of this chapter;

(3) The product incorporating the certified laser system is not independently subject to additional reporting or performance standards requirements;

(4) The incorporated laser system is not modified as defined in § 1040.10(i) of this chapter, and all performance features that apply to the incorporated laser system under § 1040.10(f) are available on the product incorporating the certified laser system;

(5) All labeling requirements that apply to the incorporated laser system under §§ 1010.2, 1010.3, 1040.10(g), and 1040.11(a)(3) of this chapter are visible on the outside of the product incorporating the certified laser system, with the exception that the certification or identification labels need not be visible on the outside of products incorporating a certified Class I laser;

(6) The incorporated laser system is installed in accordance with the instructions provided by the manufacturer of the incorporated laser system, including instructions for placing additional externally facing labels found in paragraph (e)(5) of this section, and meeting the other conditions in paragraphs (e)(1) through (8) of this section;

(7) The manufacturer of the product that incorporates the laser system provides the end user with information required under § 1040.10(h)(1) of this chapter as provided to them by the manufacturer of the incorporated laser system; and

(8) The labeling requirements under part 1010 and § 1040.10(g) of this chapter for the incorporated laser system would be met in any service configuration of the product incorporating the laser system or when the incorporated laser system is removed from the product into which it had been incorporated, and reproductions of such labels are found in the user information.

[38 FR 28631, Oct. 15, 1973, as amended at 40 FR 32257, July 31, 1975; 42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988; 88 FR 3653, Jan. 20, 2023]