[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: 21CFR1002.10]

[Page 572-573]
 
                        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 B--Required Manufacturers' Reports for Listed Electronic 
                                Products
 
Sec. 1002.10  Product reports.

    Source: 60 FR 48386, Sept. 19, 1995, unless otherwise noted.


    Every manufacturer of a product or component requiring aproduct 
report as set forth in table 1 of Sec. 1002.1 shall submit a product 
report to the Center for Devices and Radiological Health, Electronic 
Product Reports, Office of Compliance (HFZ-307), 2098 Gaither Rd., 
Rockville, MD 20850, prior to the introduction of such product into 
commerce. The report shall be distinctly

[[Page 573]]

marked ``Radiation Safety Product Report of (name of manufacturer)'' and 
shall:
    (a) Identify which listed product is being reported.
    (b) Identify each model of the listed product together with 
sufficient information concerning the manufacturer's code or other 
system of labeling to enable the Director to determine the place of 
manufacture.
    (c) Include information on all components and accessories provided 
in, on, or with the listed product that may affect the quantity, 
quality, or direction of the radiation emissions.
    (d) Describe the function, operational characteristics affecting 
radiation emissions, and intended and known uses of each model of the 
listed product.
    (e) State the standard or design specifications, if any, for each 
model with respect to electronic product radiation safety. Reference may 
be made to a Federal standard, if applicable.
    (f) For each model, describe the physical or electrical 
characteristics, such as shielding or electronic circuitry, incorporated 
into the product in order to meet the standards or specifications 
reported pursuant to paragraph (e) of this section.
    (g) Describe the methods and procedures employed, if any, in testing 
and measuring each model with respect to electronic product radiation 
safety, including the control of unnecessary, secondary, or leakage 
electronic product radiation, the applicable quality control procedures 
used for each model, and the basis for selecting such testing and 
quality control procedures.
    (h) For those products which may produce increased radiation with 
aging, describe the methods and procedures used, and frequency of 
testing of each model for durability and stability with respect to 
electronic product radiation safety. Include the basis for selecting 
such methods and procedures, or for determining that such testing and 
quality control procedures are not necessary.
    (i) Provide sufficient results of the testing, measuring, and 
quality control procedures described in accordance with paragraphs (g) 
and (h) of this section to enable the Director to determine the 
effectiveness of those test methods and procedures.
    (j) Report for each model all warning signs, labels, and 
instructions for installation, operation, and use that relate to 
electronic product radiation safety.
    (k) Provide, upon request, such other information as the Director 
may reasonably require to enable him/her to determine whether the 
manufacturer has acted or is acting in compliance with the Act and any 
standards prescribed thereunder, and to enable the Director to carry out 
the purposes of the Act.