21 CFR 1010.3 - Identification.

§ 1010.3 Identification.

(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 the product.

(2) The place and month and year of manufacture:

(i) The place of manufacture may be expressed in code provided the manufacturer has previously supplied the Director, Center for Devices and Radiological Health with the key to such code.

(ii) The month and year of manufacture shall be provided clearly and legibly, without abbreviation, and with the year shown as a four-digit number as follows:

Manufactured: (Insert Month and Year of Manufacture.)

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

(c) Every manufacturer of an electronic product to which a standard under this subchapter is applicable shall provide to the Director, Center for Devices and Radiological Health a list identifying each brand name which is applied to the product together with the full name and address of the individual or company for whom each product so branded is manufactured.

[ 40 FR 32257, July 31, 1975, as amended at 42 FR 18063, Apr. 5, 1977; 53 FR 11254, Apr. 6, 1988]

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1010 after this date.

  • 2013-06-24; vol. 78 # 121 - Monday, June 24, 2013
    1. 78 FR 37723 - Laser Products; Proposed Amendment to Performance Standard
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule.
      Submit either electronic or written comments on the proposed rule by September 23, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by July 24, 2013 (see section VIII, the “Paperwork Reduction Act of 1995” section of this document). See section IV of this document for the proposed effective date of a final rule based on this proposed rule.
      21 CFR Parts 1002, 1010, and 1040