[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1005.25]

[Page 585-586]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1005--IMPORTATION OF ELECTRONIC PRODUCTS--Table of Contents
 
              Subpart C--Bonding and Compliance Procedures
 
Sec. 1005.25  Service of process on manufacturers.

    (a) Every manufacturer of electronic products, prior to offering 
such product for importation into the United States, shall designate a 
permanent resident of the United States as the manufacturer's agent upon 
whom service of all processes, notices, orders, decisions, and 
requirements may be made for and on behalf of the manufacturer as 
provided in section 360(d) of the Radiation Control for Health and 
Safety Act of 1968 (42 U.S.C. 263h(d)) and this section. The agent may 
be an individual, a firm, or a domestic corporation. For purposes of 
this section, any number of manufacturers may designate the same agent.
    (b) A manufacturer designating an agent must address the designation 
to the Center for Devices and Radiological Health, 9200 Corporate Blvd., 
Rockville, MD 20850. It must be in writing and dated; all signatures 
must be in ink. The designation must be made in the legal form required 
to make it valid and binding on the manufacturer under the laws, 
corporate bylaws, or other requirements governing the making of the 
designation by the manufacturer at the place and time where it is made, 
and the persons or person signing the designation shall certify that it 
is so made. The designation must disclose the manufacturer's full legal 
name and the name(s) under which the manufacturer conducts the business, 
if

[[Page 586]]

applicable, the principal place of business, and mailing address. If any 
of the products of the manufacturer do not bear his legal name, the 
designation must identify the marks, trade names, or other designations 
of origin which these products bear. The designation must provide that 
it will remain in effect until withdrawn or replaced by the manufacturer 
and shall bear a declaration of acceptance duly signed by the designated 
agent. The full legal name and mailing address of the agent must be 
stated. Until rejected by the Secretary, designations are binding on the 
manufacturer even when not in compliance with all the requirements of 
this section. The designated agent may not assign performance of his 
function under the designation to another.
    (c) Service of any process, notice, order, requirement, or decision 
specified in section 360(d) of the Radiation Control for Health and 
Safety Act of 1968 may be made by registered or certified mail addressed 
to the agent with return receipt requested, or in any other manner 
authorized by law. In the absence of such a designation or if for any 
reason service on the designated agent cannot be effected, service may 
be made as provided in section 360(d) by posting such process, notice, 
order, requirement, or decision in the Office of the Director, Center 
for Devices and Radiological Health and publishing a notice that such 
service was made in the Federal Register.

[38 FR 28630, Oct. 15, 1973, as amended at 53 FR 11254, Apr. 6, 1988; 65 
FR 17137, Mar. 31, 2000]