Title 21 CFR reference

The standards listed in this subchapter are prescribed pursuant to section 534 of Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and Safety Act of 1968) (21 U.S.C. 360kk) and are applicable to electronic products as specified herein, to control electronic product radiation from such products. Standards so prescribed are subject to amendment or revocation and additional standards may be prescribed as are determined necessary for the protection of the public health and safety. [73 FR 34861, June 19, 2008]

The Director, Center for Devices and Radiological Health, may, on the basis of a written application by a manufacturer, authorize test programs other than those set forth in the standards under this subchapter for an electronic product if he determines that such products are not susceptible to satisfactory testing by the procedures set forth in the standard and that the alternative test procedures assure compliance with the standard. [40 FR 32257, July 31, 1975, as amended at 53 FR 11254, Apr. 6, 1988]

(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…

The performance standards prescribed in this subchapter shall not apply to any electronic product which is intended solely for export if: (a) Such product and the outside of any shipping container used in the export of such product are labeled or tagged to show that such product is intended for export, and (b) Such product meets all the applicable requirements of the country to which such product is intended for export. [40 FR 32257, July 31, 1975]

(a) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall set forth the information specified in paragraphs (a)(1) and (2) of this section. This information shall be provided in the form of a tag or label permanently affixed or inscribed on such product so as to be legible and readily accessible to view when the product is fully assembled for use or in such other manner as may be prescribed in the applicable standard. Except for foreign equivalent abbreviations as authorized in paragraph (a)(1) of this section all such labels or tags shall be in the English language. (1) The full name and address of the manufacturer of the product; abbreviations such as “Co.,” “Inc.,” or their foreign equivalents and the first and middle initials of individuals may be used. Where products are sold under a name other than that of the manufacturer of the product, the full name and address of the individual or company under whose name the product was sold may be set forth, provided such individual or company has previously suppled the Director, Center for Devices and Radiological Health with sufficient information to identify the manufacturer of…

Criteria for variances.(a) (1) Upon application by a manufacturer (including an assembler), the Director, Center for Devices and Radiological Health, Food and Drug Administration, may grant a variance from one or more provisions of any performance standard under subchapter J of this chapter for an electronic product subject to such standard when the Director determines that granting such a variance is in keeping with the purposes of Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act (formerly the Radiation Control for Health and Safety Act of 1968), and: (i) The scope of the requested variance is so limited in its applicability as not to justify an amendment to the standard, or (ii) There is not sufficient time for the promulgation of an amendment to the standard. (2) The issuance of the variance shall be based upon a determination that: (i) The product utilizes an alternate means for providing radiation safety or protection equal to or greater than that provided by products meeting all requirements of the applicable standard, or (ii) The product performs a function or is intended for a purpose which could not be performed or…

Criteria for exemption.(a) Upon application by a manufacturer (including assembler) or by a U.S. department or agency, the Director, Center for Devices and Radiological Health, Food and Drug Administration, may grant an exemption from any performance standard under subchapter J of this chapter for an electronic product, or class of products, otherwise subject to such standard when he determines that such electronic product or class is intended for use by departments or agencies of the United States and meets the criteria set forth in paragraph (a) (1) or (2) of this section. (1) The procuring agency shall prescribe procurement specifications for the product or class of products governing emissions of electronic product radiation, and the product or class shall be of a type used solely or predominantly by a department or agency of the United States. (2) The product or class of products is intended for research, investigations, studies, demonstration, or training, or for reasons of national security. Consultation between the procuring agency and the Food and Drug Administration.(b) The United States department or agency that intends to procure or manufacture a product or class of…