Fda consumer update – UTStarcom 860 User Manual

Page 65

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129

FDA CONSUMER UPDATE

128

FDA CONSUMER UPDATE

FDA: U.S. Food and Drug Administration -Center for Devices
and Radiological Health Consumer Update on Wireless
Phones

1. Do wireless phones pose a health hazard?
The available scientific evidence does not show that any
health problems are associated with using wireless phones.
There is no proof, however, that wireless phones are
absolutely safe. Wireless phones emit low levels of
radiofrequency energy (RF) in the microwave range while
being used. They also emit very low levels of RF when in the
stand-by mode. Whereas high levels of RF can produce
health effects (by heating tissue), exposure to low level RF
that does not produce heating effects causes no known
adverse health effects. Many studies of low level RF
exposures have not found any biological effects. Some
studies have suggested that some biological effects may
occur, but such findings have not been confirmed by
additional research. In some cases, other researchers have
had difficulty in reproducing those studies, or in determining
the reasons for inconsistent results.

2. What is FDA’s role concerning the safety of wireless
phones?
Under the law, FDA does not review the safety of radiation-
emitting consumer products such as wireless phones before
they can be sold, as it does with new drugs or medical de-
vices. However, the agency has authority to take action if
wire-less phones are shown to emit radiofrequency energy
(RF) at a level that is hazardous to the user. In such a case,
FDA could require the manufacturers of wireless phones to
notify users of the health hazard and to repair, replace or
recall the phones so that the hazard no longer exists.

Although the existing scientific data do not justify FDA
regulatory actions, FDA has urged the wireless phone industry
to take a number of steps, including the following:

• Support needed research into possible biological effects

of RF of the type emitted by wireless phones

• Design wireless phones in a way that minimizes any RF

exposure to the user that is not necessary for device
function

• Cooperate in providing users of wireless phones with the

best possible information on possible effects of wireless
phone use on human health.

FDA belongs to an interagency working group of the federal
agencies that have responsibility for different aspects of RF
safety to ensure coordinated efforts at the federal level. The
following agencies belong to this working group:

• National Institute for Occupational Safety and Health
• Environmental Protection Agency
• Federal Communications Commission
• Occupational Safety and Health Administration
• National Telecommunications and Information

Administration

The National Institutes of Health participates in some inter-
agency working group activities, as well. FDA shares
regulatory responsibilities for wireless phones with the Federal
Communications Commission (FCC). All phones that are sold
in the United States must comply with FCC safety guidelines
that limit RF exposure. FCC relies on FDA and other health
agencies for safety questions about wireless phones. FCC
also regulates the base stations that the wireless phone
networks rely upon. While these base stations operate at
higher power than do the wireless phones themselves, the RF
exposures that people get from these base stations are
typically thousands of times lower than those they can get
from wire-less phones. Base stations are thus not the subject
of the safety questions discussed in this document.

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