TIP: Click on subject to list as thread! ANSI
echo: consprcy
to: All
from: Steve Asher
date: 2002-10-24 01:43:34
subject: US FDA Ruling On Subdermal VeriChip

=
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."  

                            -==-

Source: Applied Digital Solutions - http://www.adsx.com/news/2002/102202.html

Cheers, Steve..

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