[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1010.3]

[Page 616-617]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1010_PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: 
GENERAL--Table of Contents
 
                      Subpart A_General Provisions
 
Sec. 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.

[[Page 617]]

    (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]