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For Your Safety 130
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 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 does not justify FDA regulatory actions,
the FDA has urged the 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 devices;
• Design 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 devices with the best possible information on
possible effects of 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 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 devices.
The FCC also regulates the base stations that the device networks rely upon. While
these base stations operate at higher power than do the devices themselves, the
RF exposures that people get from these base stations are typically thousands of
times lower than those they can get from devices. Base stations are thus not the
subject of the safety questions discussed in this document.
3. What kinds of devices are the subject of this update?
The term “wireless device” refers here to handheld wireless devices with built-in
antennas, often called “cell”, “mobile”, or “PCS” devices. These types of wireless
devices can expose the user to measurable Radio Frequency (RF) energy because
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