[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1004.2]

[Page 567]
 
                        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. 1004.2  Plans for the repair of electronic products.

    Every plan for bringing an electronic product into conformity with 
applicable Federal standards or for remedying any defect in such 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 specific modifications, alterations, changes, repairs, 
corrections, or adjustments to be made to bring the product into 
conformity or remedy any defect.
    (d) The manner in which the operations described in paragraph (c) 
will be accomplished, including the procedure for obtaining access to, 
or possession of, the products and the location where such operations 
will be performed.
    (e) The technical data, test results or studies demonstrating the 
effectiveness of the proposed remedial action.
    (f) A time limit, reasonable in light of the circumstances, for 
completion of the operations.
    (g) The system by which the manufacturer will provide reimbursement 
for any transportation expenses incurred in connection with having such 
product brought into conformity or having any defect remedied.
    (h) 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;
    (1) That the manufacturer, at his expense, will repair the 
electronic product involved,
    (2) Of the method by which the manufacturer will obtain access to or 
possession of the product to make such repairs,
    (3) That the manufacturer will reimburse such persons for any 
transportation expenses incurred in connection with making such repairs, 
and
    (4) Of the manner in which such reimbursement will be effected.
    (i) An assurance that the manufacturer will provide the Secretary 
with progress reports on the effectiveness of the plan, including the 
number of electronic products repaired.