[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.1]

[Page 14]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 801--LABELING--Table of Contents
 
                 Subpart A--General Labeling Provisions
 
Sec. 801.1  Medical devices; name and place of business of manufacturer, packer or distributor.


    (a) The label of a device in package form shall specify 
conspicuously the name and place of business of the manufacturer, 
packer, or distributor.
    (b) The requirement for declaration of the name of the manufacturer, 
packer, or distributor shall be deemed to be satisfied, in the case of a 
corporation, only by the actual corporate name which may be preceded or 
followed by the name of the particular division of the corporation. 
Abbreviations for ``Company,'' ``Incorporated,'' etc., may be used and 
``The'' may be omitted. In the case of an individual, partnership, or 
association, the name under which the business is conducted shall be 
used.
    (c) Where a device is not manufactured by the person whose name 
appears on the label, the name shall be qualified by a phrase that 
reveals the connection such person has with such device; such as, 
``Manufactured for ------'', ``Distributed by ----------'', or any other 
wording that expresses the facts.
    (d) The statement of the place of business shall include the street 
address, city, State, and Zip Code; however, the street address may be 
omitted if it is shown in a current city directory or telephone 
directory. The requirement for inclusion of the ZIP Code shall apply 
only to consumer commodity labels developed or revised after the 
effective date of this section. In the case of nonconsumer packages, the 
ZIP Code shall appear on either the label or the labeling (including the 
invoice).
    (e) If a person manufactures, packs, or distributes a device at a 
place other than his principal place of business, the label may state 
the principal place of business in lieu of the actual place where such 
device was manufactured or packed or is to be distributed, unless such 
statement would be misleading.