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For Your Safety 184
2. What is the FDA’s role concerning the safety of wireless
devices?
Under the law, the FDA does not review the safety of radiation-emitting consumer
products such as wireless devices before they can be sold, as it does with new
drugs or medical devices. However, the agency has authority to take action if
wireless devices are shown to emit Radio Frequency (RF) energy at a level that is
hazardous to the user. In such a case, the FDA could require the manufacturers of
wireless devices to notify users of the health hazard and to repair, replace, or recall
the devices so that the hazard no longer exists.
Although the existing scientific data do not justify FDA regulatory actions, the FDA
has urged the wireless device 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 devices;
• Design wireless devices 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 devices with the best possible
information on possible effects of wireless device 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
• Occupational Safety and Health Administration
• National Telecommunications and Information Administration
The National Institutes of Health participates in some interagency working group
activities, as well.
The FDA shares regulatory responsibilities for wireless devices with the Federal
Communications Commission (FCC). All devices that are sold in the United States
must comply with FCC safety guidelines that limit RF exposure. The FCC relies on
the FDA and other health agencies for safety questions about wireless devices.
The FCC also regulates the base stations that the wireless device networks rely
upon. While these base stations operate at higher power than do the wireless
devices themselves, the RF exposures that people get from these base stations are
typically thousands of times lower than those they can get from wireless devices.
Base stations are thus not the subject of the safety questions discussed in this
document.
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