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Section 12: Maintenance, Safety, and

Troubleshooting

What is the FDA's role concerning the safety of wireless phones?

Under the law, the 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 radio

frequency 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 scientic data does not justify FDA regulatory

actions, the 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; and

 Cooperate in providing users of wireless phones with the best possible

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

The 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 Institute of Health participates in some interagency

working group activities, as well.

The 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. The FCC relies on FDA and other health agencies for safety

questions about wireless phones.

The 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

primary subject of the safety questions discussed in this document.

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