Fda consumer update, Ch 10 – UTStarcom PN-820 User Manual

Page 272

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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


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

devices. However, the agency has authority to take action if wireless 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 wireless phones. Base stations are thus not the subject of the safety questions

discussed in this document.

U.S. Food and Drug Administration – Center for Devices and

Radiological Health Consumer Update on Wireless Phones