User Manual

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The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health Consumer Update on
Wireless Devices:
1. 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 wireless devices so that the hazard no longer exists.
Although the existing scientific data does not justify FDA regulatory actions, the FDA has urged the wireless device
industry to take a number of steps, including the following:
1. Support current and future research regarding possible biological effects of the type of RF emitted by wireless
devices;
2. Design wireless devices in a way that minimizes any RF exposure to the user that is not necessary for device
function; and
3. Cooperate in providing users of wireless devices with complete and accurate information regarding possible
effects of wireless device use on human health and safety.
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:
1. National Institute for Occupational Safety and Health
2. Environmental Protection Agency
3. Occupational Safety and Health Administration
4. 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 wireless
devices that are sold in the United States must comply with FCC safety guidelines that act to 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.
2. Do wireless devices pose a health hazard?
Current scientific evidence does not show that any health problems are associated with using wireless devices. There is
no proof, however, that wireless devices are absolutely safe. Wireless devices emit low levels of Radio Frequency (RF)
energy while operating microwave ranges (which also emit very low levels of RF when they are in standby mode).
While high levels of RF can produce health effects (by heating tissue), exposure to low-level RF that does not produce
heating effects results in no known adverse health effects. Many studies of low-level RF exposures have not uncovered
any biological effects. Although some studies have suggested that some biological effects may occur, such findings have
not been confirmed by additional research. In some cases, other researchers have had difficulty in reproducing those
studies, and/or determining the reasons for inconsistent results.
3. What are the results of the research done already?
The research conducted thus far has produced conflicting results, and many studies have suffered from flaws in their
research methods. Animal experiments investigating the effects of Radio Frequency (RF) energy exposures
characteristic of wireless devices have yielded conflicting results that often cannot be repeated in other laboratories. A
few animal studies, however, have suggested that low levels of RF could accelerate the development of cancer in
laboratory animals. However, many of the studies that showed increased tumor development used animals that had
been genetically engineered or treated with cancer-causing chemicals so as to be pre-disposed to develop cancer in the
absence of RF exposure. Other studies exposed the animals to RF for up to 22 hours per day. These conditions are not
similar to the conditions under which people use wireless devices, so it is largely unknown what the results of such
studies mean for human health and safety. Three large epidemiology studies have been published since December 2000.