Exhibit 99.2
[SEAL] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
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Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
OCT 12 2004
James Santelli
Vice President, Finance and Chief Financial Office
Digital Angel Corporation
490 Villaome Avenue
South Saint Paul, Minnesota 55075-2443
Re: K033440
Evaluation of Automatic Class III Designation
VeriChip(TM) Health Information Microtransponder System
Regulation Number: 21 CFR 880.6300
Classification: Class II
Product Code: NRV
Dear Mr. Santelli:
The Center for Devices and Radiological Health (CDRH) of the Food and Drug
Administration (FDA) has completed its review of your petition for
classification of the VeriChip(TM) Health Information Microtransponder
System, a prescription device, as per 21 CFR 801.109, that includes the
VeriChip(TM) Pocket Reader and the VeriChip(TM) with the insertion device.
The VeriChip(TM) Pocket Reader is indicated for use as a portable instrument
that non-invasively reads the ID number of an implantable microchip that is
inserted into the arm of the patient. When activated, the VeriChip Pocket
Reader displays a unique identification number that may be used to access
the patient's identity and authorized health information from a secure
database. The VeriChip(TM) is indicated for use as a miniature, implantable
microchip that is inserted into the subcutaneous tissue of the patient. The
VeriChip(TM) provides the patient a unique identification number that may be
used to access a database containing the patient's identity and health
information.
FDA has determined that this device, and substantially equivalent devices of
this generic type, should be classified into class II. This order,
therefore, classifies the VeriChip(TM) Health Information Microtransponder
System, and substantially equivalent devices of this generic type into class
II under the generic name, Implantable Radiofrequency Transponder System for
Patient Identification and Health Information. This order also identifies
the special control applicable to this device, entitled, "Class II Special
Controls Guidance Document: Implantable Radiofrequency Transponder System
for Patient Identification and Health Information."
FDA identifies this generic type of device as:
21 CFR 880.6300 Implantable Radiofrequency Transponder System for
Patient Identification and Health Information
Page 2 - Mr. Santelli
An implantable radiofrequency transponder system is intended to enable
access to secure patient identification and corresponding health
information. This system may include a passive implanted transponder,
inserter, and scanner. The implanted transponder is used only to store
a unique electronic identification code which is read by the scanner.
The identification code is used to access patient identity and
corresponding health information stored in a database.
In accordance with section 513(f)(1) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360c(f)(1)) (the act), devices that were not in commercial
distribution prior to May 28, 1976 (the date of enactment of the Medical
Device Amendments of 1976 (the amendments)), generally referred to as
postamendments devices, are classified automatically by statute into class
III without any FDA rulemaking process. These devices remain in class III
and require premarket approval, unless and until the device is classified or
reclassified into class I or II or FDA issues an order finding the device to
be substantially equivalent, in accordance with section 513(i) of the act
(21 U.S.C. 360c(i)), to a predicate device that does not require premarket
approval. The agency determines whether new devices are substantially
equivalent to previously marketed devices by means of premarket notification
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and Part 807 of
the FDA regulations (21 CFR 807).
Section 513(f)(2) of the act provides that any person who submits a
premarket notification under section 510(k) for a device may, within 30 days
after receiving an order classifying the device in class III under section
513(f)(1), request FDA to classify the device under the criteria set forth
in section 513(a)(1). FDA shall, within 60 days of receiving such a
request, classify the device. This classification shall be the initial
classification of the device type. Within 30 days after the issuance of an
order classifying the device, FDA must publish a notice in the Federal
Register classifying the device type.
On August 4, 2004, FDA filed your petition requesting classification of the
VeriChip(TM) Health Information Microtransponder System into class II. The
petition was submitted under section 513(f)(2) of the act. In accordance
with section 513(f)(1) of the act, FDA issued an order on July 22, 2004,
automatically classifying the VeriChip(TM) Health Information
Microtransponder System in class III, because it was not within a type of
device that was introduced or delivered for introduction into interstate
commerce for commercial distribution before May 28, 1976, which was
subsequently reclassified into class I or class II. In order to classify the
VeriChip(TM) Health Information Microtransponder System into class I or II,
it is necessary that the proposed class have sufficient regulatory controls
to provide reasonable assurance of the safety and effectiveness of the
device for its intended use.
Page 3 - Mr. Santelli
Based on the information submitted in the petition for the VeriChip(TM)
Health Information Microtransponder System, FDA has determined that the
VeriChip(TM) Health Information Microtransponder System can be classified in
class II with the establishment of special controls. FDA believes that class
II special controls provide reasonable assurance of the safety and
effectiveness of the device.
The potential risks to health associated with the device are: adverse tissue
reaction; migration of implanted transponder; compromised information
security; failure of implanted transponder; failure of inserter; failure of
electronic scanner; electromagnetic interference; electrical hazards;
magnetic resonance imaging incompatibility; and needle stick. The special
controls document aids in mitigating the risks by identifying performance
and safety testing, and appropriate labeling. Thus, in addition to the
general controls of the act, an Implantable Radiofrequency Transponder
System for Patient Identification and Health Information is subject to the
following special control: Class II Special Controls Guidance Document:
Implantable Radiofrequency Transponder System for Patient Identification and
Health Information.
Section 510(m) of the act provides that FDA may exempt a class II device
from the premarket notification requirements under section 510(k) of the
act, if FDA determines that premarket notification is not necessary to
provide reasonable assurance of the safety and effectiveness of the device.
FDA has determined premarket notification is not necessary to provide
reasonable assurance of the safety and effectiveness of an Implantable
Radiofrequency Transponder System for Patient Identification and Health
Information and, therefore, the device type is exempt from the premarket
notification requirements. Thus, persons who intend to market this device
type need not submit to FDA a premarket notification submission containing
information on an Implantable Radiofrequency Transponder System for Patient
Identification and Health Information, unless they exceed the limitations on
exemptions in 21 CFR 880.9 (e.g., different intended use or fundamental
scientific technology).
A notice announcing this classification order will be published in the
Federal Register. A copy of this order and supporting documentation will be
on file in the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852 and will
be available for inspection between 9 a.m. and 4 p.m., Monday through
Friday.
Page 4 - Mr. Santelli
As a result of this order, you may immediately market this device, subject
to the general control provisions of the Act and the special controls
identified in this order. If you have any questions concerning this
classification order, please contact Gail Gantt, R.N. at (301) 594-1287.
Sincerely yours,
/s/ Donna-Bea Tillman
Donna-Bea Tillman, Ph.D
Director
Office of Device Evaluation
Center for Devices and
Radiological Health