Subject: [NEXTEL-1] 510k Application Submitted to Food and Drug Administration Seeking Permission to Market Subdermal RFID VeriChip's Healthcare Applications in the United States

From: [email-masked]
Date: Wed, 29 Oct 2003 11:19:20 -0500

510k Application Submitted to Food and Drug Administration
Seeking Permission to Market Subdermal RFID VeriChip's
Healthcare Applications in the United States
Source: Business Wire
Publication date: 2003-10-29

PALM BEACH, Fla.--(BUSINESS WIRE)--Oct. 29, 2003--

FDA Ruled Last October That VeriChip is a Regulated Medical Device

"When Marketed to Provide Information to Assist in the Diagnosis or

Treatment of Injury or Illness"

Applied Digital Solutions, Inc. (Nasdaq: ADSX) an advanced technology
development company, announced today that a 510(k) application has
been submitted to the United States Food and Drug Administration (FDA)
seeking the agency's permission to market VeriChip's healthcare
information applications in the United States.

About the size of a grain of rice, VeriChip(TM) is the world's first
subdermal, radio frequency identification (RFID) microchip designed for
human use in a variety of security, financial, emergency identification
and,
subject to FDA clearance, healthcare applications. Each VeriChip
contains a unique verification number that is captured by briefly
passing a
proprietary scanner over the VeriChip. Once inserted just under the skin
in
a brief outpatient "chipping" procedure, the VeriChip is inconspicuous
to
the naked eye.

The detailed 510(k) submission was necessitated by the FDA's ruling last

October that VeriChip is a regulated medical device "when marketed to
provide information to assist in the diagnosis or treatment of injury or

illness." In that same ruling, the FDA determined that VeriChip was not
a
regulated device for its "security, financial, and personal
identification/safety applications."

In submitting the 510(k) application, frequently referred to as a
"premarket
notification submission," the Company is following the process outlined
by
an FDA representative at a public seminar about human implantable
microchips at the National Academies in Washington, D.C., on November
15, 2002. During this seminar, the FDA official described a submission
process for obtaining premarket clearance for safe and effective
implantable microchips for human use.

Commenting on the 510(k) application and the regulatory review process
ahead, Michael Krawitz, General Counsel of Applied Digital Solutions,
said: "The specific approach outlined by the FDA involves submitting a
510(k) premarket application and, if necessary, a so-called draft
Special
Guidance to support 'de novo' review. Now that the 510(k) application
has
been submitted, the FDA will formally determine whether or not a
predicate device has already been cleared by the FDA. If the FDA
concludes that no such predicate device exists, the VeriChip application

will be reviewed through the 'de novo' process to make a final
determination regarding the clearance and categorization of VeriChip, as

well as any specific regulatory requirements that may be necessary.
While the timetable for all of this is not defined, we understand that
the
entire process could take several months or more to run its course."

Assuming clearance is obtained from the FDA, the Company plans to
market VeriChip's family of innovative and potentially life-saving
healthcare
information applications in the United States using the VeriMed(TM)
product name. VeriMed's many potential healthcare-related uses include
the following:

-- Implanted medical device identification

-- Emergency access to patient-supplied health information

-- Portable medical records access

-- In-hospital patient identification

-- Medical facility connectivity via patient

-- Patient/therapy integration

-- Inter-facility patient identification

-- Disease/treatment management of at-risk populations (e.g.

vaccination history)
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