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For Your Safety 136
FDA Consumer Update
The U.S. Food and Drug Administration’s Center for Devices and
Radiological Health Consumer Update on Mobile Devices:
1. Do wireless devices pose a health hazard?
The available scientific evidence does not show that any health problems are
associated with using devices. There is no proof, however, that devices are
absolutely safe. Devices emit low levels of Radio Frequency (RF) energy in the
microwave range while being used. They also emit very low levels of RF when in
standby 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 the FDA’s role concerning the safety of devices?
Under the law, the FDA does not review the safety of radiation-emitting consumer
products such as devices before they can be sold, as it does with new drugs or
medical devices. However, the agency has authority to take action if 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 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.
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