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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
Please note: If you are unsure if your product emits radiation, please refer to "Does Your Product Emit Radiation?"
Labeling of radiation-emitting products applies to all products which emit
sonic, infrasonic, or ultrasonic radiation as the result of operation of an
electronic circuit. It thus applies to medical devices which emit sonic, infrasonic,
or ultrasonic radiation as the result of operation of an electronic circuit
in addition to the general labeling requirements for medical devices. Radiation-emitting
devices include electronic products that emit radiation either by design (e.g.,
X-ray equipment) or as a consequence of operation (e.g., television set), but
exclude products that emit radiation as a result of the decay of a radioactive
element or isotope (e.g., an ionization type smoke detector). Section 358 of
the Radiation Control for Health and Safety Act (RCHSA) of 1968 authorizes the
development of Federal standards for these types of radiation producing products.
These standards are contained within the regulations listed under 21 CFR Part
1000. The corresponding regulations are listed by product type in subsequent
headings of this section. This booklet will cover only those portions of these
standards related to product labeling and will not attempt to address technical
specifications contained in the standards. Thus, the nature and placement of
labeling may vary from those discussed under GENERAL DEVICE
LABELING REQUIREMENTS; however, the concepts of "label" and "labeling"
remain the same, e.g., the "label" of a device might consist of a
warning label on the console of an X-ray system, as well as a red indicator
light on the panel; the "label" of a television receiver might consist
not only of the name of the manufacturer, date of manufacture, and user caution
statements, but also of labels inside the receiver to high voltages and X-ray
shielding.
At the present time, as a matter of choice and practicality, FDA does not choose
to actively regulate some common household products such as radios and incandescent
light bulbs; however, if such products were found to pose a consumer hazard,
the FDA could choose to regulate them. A good example of a hazard to consumers
is the cordless telephone. As a result of consumer complaints, and confirmed
injuries due to the placement, volume, and frequencies of ringers in certain
brands of telephones, FDA set and enforced guidelines to prevent hearing injuries.
This section will cover labeling of radiation-emitting medical
and other electronic devices. Due to the amount of technical data contained
in the corresponding sections of the CFR, reprints of the CFR sections pertaining
to laser labeling will be used where appropriate to demonstrate format requirements.
Numbers appearing in parentheses next to subject headings are the corresponding
sections of 21 CFR.
Manufacturers of electronic products covered under a radiation performance
standard shall provide the following information on a tag or label permanently
affixed or inscribed on the product. The following information should be accessible
to view when the product is fully assembled:
"MANUFACTURED: (Insert Month and Year of Manufacture)"
In a case where it is not feasible to affix identification labeling in accordance
with the above, the Director of CDRH may approve an application for an alternate
means of identification.
The manufacturer of an EPRC product subject to a standard must furnish the
Director of CDRH with a complete listing of all brand names and the names and
addresses of the individuals or companies for which electronic products are
manufactured under a standard.
Electronic products intended for United States Government use may be exempted
from any performance standard upon application to the Director of CDRH by manufacturer,
assembler, or a U.S. department or agency.
All products intended solely for export shall be labeled or tagged to show
that they are intended for export.
The manufacturer of any electronic product covered by an exemption from performance
standards (i.e., standards, other than labeling, which are not covered in this
chapter) must permanently attach a tag or label stating:
"This electronic product has been exempted from the Food and Drug Administration
radiation safety performance standards prescribed in the Code of Federal Regulations,
Title 21, Chapter I, Subchapter J, pursuant to Exemption No. ,
Granted on / / ."
Television Receivers 21
CFR 1020.10
A television receiver is an electronic product designed to receive and display
a television picture through broadcast, cable, or closed circuit television.
Computer monitors which can display any graphical image are included in the
standard; monitors limited by design to display only alpha-numeric characters
are excluded.
Cold-cathode Gas Discharge Tubes 21 CFR 1020.20
Cold-cathode discharge tubes are devices designed to demonstrate the effects
of a flow of electrons or the production of X-rays.
Diagnostic X-ray Systems 21
CFR 1020.30
Diagnostic X-ray systems incorporate one or more certified components. The
components of a diagnostic X-ray system which require certification are listed
in 21
CFR 1020.30(a). Both diagnostic X-ray systems and computed tomography (CT)
X-ray systems manufactured before November 29, 1984 [prior to this date the
CT requirements were general, but the components still had to be certified.
After this date, there were specific CT performance requirements], are subject
to the following requirements:
"WARNING: This X-ray unit may be dangerous to patient and operator
unless safe exposure factors and operating instructions are observed."
"Temporarily Installed Compatible Component. This certified component
has been assembled, installed, adjusted, and tested by me according to the
instructions provided by the manufacturer. Signature; Company Name; Street
Address, City, State, Zip Code, and Date of Installation."
Radiographic Equipment 21
CFR 1020.31
Fluoroscopic Equipment 21
CFR 1020.32
Cabinet X-ray Systems 21
CFR 1020.40
'CAUTION: X-RAYS PRODUCED WHEN ENERGIZED'
"CAUTION: DO NOT INSERT ANY PART OF THE BODY WHEN SYSTEM IS ENERGIZED - X-RAY HAZARD."
Microwave and Radio Frequency(RF)Emitting Products 21
CFR 1030.10
A microwave oven is a device designed to heat, cook, or dry food thoroughly
through the application of electromagnetic energy in the normal ISM heating
bands ranging from 890 megahertz to 6,000 megahertz. The definition in the standard
is limited to those manufactured for use in homes, restaurants, food vending,
or service establishments, on interstate carriers, and in similar facilities.
Lasers 21
CFR 1040.10
Lasers are devices capable of producing intense radiation at a specific wavelength
both for medical and industrial purposes. In addition to the general labeling
requirements for firm name, street address, state, and zip code, lasers require
labeling specific to their type, class, wavelength, and power output. Due to
the numerous combinations of labeling types dictated by class, wavelength, and
power output, it would not be practical to cover each in specific detail in
this booklet. Instead, use the following sample label types in conjunction with
the following reprints of CFR sections to demonstrate specific labeling requirements.
Sunlamp Products and Ultraviolet Lamps 21
CFR 1040.20
An ultraviolet lamp is any lamp that produces ultraviolet radiation in the
wavelength interval of 200 to 400 nanometers in air that is intended for use
in any sunlamp product.
All labels are to be affixed or inscribed on an exterior surface that can be
easily seen by the person being exposed immediately before use of the product.
Sunlamp Products
A sunlamp product is any electronic product designed to incorporate one or
more ultraviolet lamps and intended for irradiation of any part of the living
human body, by ultraviolet radiation with wavelengths in air between 200 and
400 nanometers, to induce skin tanning.
In addition the label must also contain:
Ultraviolet Lamps
- The words: "Sunlamp - DANGER - Ultraviolet radiation. Follow instructions;"
- The model identification; and
- The words: "Use ONLY in fixtures equipped with a timer."
Ultrasonic Therapy Products 21
CFR 1050.10
In addition to the general labeling requirements, ultrasonic therapy products
are subject to the following additional labeling requirements:
Updated 12/7/2001
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