[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: 21CFR1004.4]

[Page 611-612]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1004_REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC 
PRODUCTS--Table of Contents
 
Sec. 1004.4  Plans for refunding the cost of electronic products.

    Every plan for refunding the cost of an electronic product shall be 
submitted to the Secretary in writing, and in addition to other relevant 
information which the Secretary may require, shall include:
    (a) Identification of the product involved.
    (b) The approximate number of defective product units which have 
left the place of manufacture.
    (c) The manner in which the refund operation will be effected 
including the procedure for obtaining possession of the product for 
which the refund is to be made.
    (d) The steps which the manufacturer will take to insure that the 
defective products will not be reintroduced into commerce, until it 
complies with each applicable Federal standard and has no defect 
relating to the safety of its use.
    (e) A time limit, reasonable in light of the circumstances, for 
obtaining the product and making the refund.
    (f) A statement that the manufacturer will refund the cost of such 
product together with the information the manufacturer has used to 
determine the amount of the refund.
    (g) The text of the statement which the manufacturer will send to 
the persons specified in Sec. 1003.10(b) of this chapter informing such 
persons;

[[Page 612]]

    (1) That the manufacturer, at his expense, will refund the cost of 
the electronic product plus any transportation costs,
    (2) Of the amount to be refunded exclusive of transportation costs,
    (3) Of the method by which the manufacturer will obtain possession 
of the product and make the refund.
    (h) An assurance that the manufacturer will provide the Secretary 
with progress reports on the effectiveness of the plan, including the 
number of refunds made.