User's Manual

64 Certification and safety information for the United States and ...
What is FDA's role concerning the safety of wireless phones?
Under the law, FDA does not review the safety of radiation-emitting
consumer products such as wireless phones before they can be
sold, as it does with new drugs or medical devices. However, the
agency has authority to take action if wireless phones are shown to
emit radiofrequency energy (RF) at a level that is hazardous to the
user. In such a case, FDA could require the manufacturers of
wireless phones to notify users of the health hazard and to repair,
replace or recall the phones so that the hazard no longer exists.
Although the existing scientific data do not justify FDA regulatory
actions, FDA has urged the wireless phone 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 phones;
- Design wireless phones 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 phones with the best
possible information on possible effects of wireless phone use on
human health.
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
- Federal Communications Commission
- Occupational Safety and Health Administration
- National Telecommunications and Information Administration
The National Institutes of Health participates in some interagency
working group activities, as well.
FDA shares regulatory responsibilities for wireless phones with the
Federal Communications Commission (FCC). All phones that are
sold in the United States must comply with FCC safety guidelines
that limit RF exposure. FCC relies on FDA and other health
agencies for safety questions about wireless phones.
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