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| subject: | US FDA Ruling On Subdermal VeriChip |
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FDA RULING - SUBDERMAL VERICHIP IS NOT A REGULATED MEDICAL DEVICE "FOR
SECURITY, FINANCIAL, AND PERSONAL IDENTIFICATION/SAFETY APPLICATIONS"
Company will immediately resume sales, marketing and distribution
efforts of VeriChip in the United States
PALM BEACH, FLu October 22, 2002 u Applied Digital Solutions, Inc.
(Nasdaq: ADSX), an advanced technology development company, today
announced that the Food and Drug Administration (FDA) has determined
that VeriChip is not a regulated medical device "for security,
financial, and personal identification/safety applications."
The Agency specified in its ruling that VeriChip is a regulated medical
device for health information applications "when marketed to provide
information to assist in the diagnosis or treatment of injury or illness."
The ruling was communicated to the Company by letter from the FDA.
The FDA's decision - responding to the Company's pending "513(g)"
applications - comes five months after the Company voluntarily
suspended marketing of VeriChip in the United States pending review
of VeriChip by the FDA. As a result of the FDA's ruling, the Company
will immediately resume sales, marketing and distribution efforts of
VeriChip in the United States for security, financial, and personal
identification/safety applications.
Commenting on the FDA's ruling, Scott R. Silverman, President of
Applied Digital Solutions, said: "We are very pleased with the FDA's
decision. Although the process took longer than expected, the
Company is thrilled to be able to bring this exciting technology
to market in the United States. In the next several days, we will
outline our domestic sales, marketing and distribution plans and
provide further updates on our international sales and expansion
efforts."
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Source: Applied Digital Solutions - http://www.adsx.com/news/2002/102202.html
Cheers, Steve..
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