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.
What is FDA's role concerning the safety of wireless express cards?
Under the law, FDA does not review the safety of radiation-emitting consumer
products such as wireless express cards before they can be sold, as it does with
new drugs or medical devices. However, the agency has authority to take action if
wireless express cards are shown to emit radio frequency energy (RF) at a level
that is hazardous to the user. In such a case, FDA could require the manufacturers
of wireless express cards to notify users of the health hazard and to repair, replace
or recall the express cards so that the hazard no longer exists.
Although the existing scientific data do not justify FDA regulatory actions, FDA has
urged the wireless express card 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 express cards;
“Design wireless express cards 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 express cards with the best possible
information on possible effects of wireless express card 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 express cards with the Federal
Communications Commission (FCC). All express cards that are sold in the United
States must comply with FCC safety guidelines that limit RF exposure. FCC relies on
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