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Safety
114
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
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