[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: 21CFR1002.30]

[Page 574-575]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 1002--RECORDS AND REPORTS--Table of Contents
 
                    Subpart D--Manufacturers' Records
 
Sec. 1002.30  Records to be maintained by manufacturers.


    (a) Manufacturers of products listed under table 1 of Sec. 1002.1 
shall establish and maintain the following records with respect to such 
products:
    (1) Description of the quality control procedures with respect to 
electronic product radiation safety.
    (2) Records of the results of tests for electronic product radiation 
safety, including the control of unnecessary, secondary or leakage 
electronic product radiation, the methods, devices, and procedures used 
in such tests, and the

[[Page 575]]

basis for selecting such methods, devices, and procedures.
    (3) For those products displaying aging effects which may increase 
electronic product radiation emission, records of the results of tests 
for durability and stability of the product, and the basis for selecting 
these tests.
    (4) Copies of all written communications between the manufacturer 
and dealers, distributors, and purchasers concerning radiation safety 
including complaints, investigations, instructions, or explanations 
affecting the use, repair, adjustment, maintenance, or testing of the 
listed product.
    (5) Data on production and sales volume levels if available.
    (b) In addition to the records required by paragraph (a) of this 
section, manufacturers of products listed in paragraph (c) of 
Sec. 1002.61 shall establish and maintain the following records with 
respect to such products:
    (1) A record of the manufacturer's distribution of products in a 
form which will enable the tracing of specific products or production 
lots to distributors or to dealers in those instances in which the 
manufacturer distributes directly to dealers.
    (2) Records received from dealers or distributors pursuant to 
Sec. 1002.41.

[38 FR 28625, Oct. 15, 1973, as amended at 60 FR 48386, Sept. 19, 1995]