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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR1002.10]
See Related Information on Product reports. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER J--RADIOLOGICAL HEALTH

PART 1002 -- RECORDS AND REPORTS

Subpart B--Required Manufacturers' Reports for Listed Electronic Products

Sec. 1002.10 Product reports.

Every manufacturer of a product or component requiring a product report as set forth in table 1 of 1002.1 shall submit a product report to the Food and Drug Administration, Center for Devices and Radiological Health, ATTN: Electronic Product Reports, Document Mail Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002, prior to the introduction of such product into commerce. The report shall be distinctly 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.

[60 FR 48386, Sept. 19, 1995, as amended at 72 FR 17400, Apr. 9, 2007; 75 FR 20916, Apr. 22, 2010]

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