베리칩에 대한 오해?

 이번 종말론 세미나를 하면서

다시 한번 사람들이 베리칩에 대하여 큰 관심을 가지고 있다는 사실을 알았습니다.

그런데 많은 사람들은 미국의 의료 개혁 법이 시행되면 강제로

베리칩을 받게 하는 것을 오해하고 있습니다.

아래에 제가 HR 3200 문서를 조사하여 해당 문구를 인용하였습니다.

Class II 장치라는 것은 주사기, 보청기 등등 인체에 넣을수 있는 장치입니다.

물론 베리칩도 포함합니다.

의료등록을 해야한다고 되어 있는 것은 아래 있는 바와 같이 "국가 의료장치 등록" 입니다.

"국가 의료보험 등록" 이 아닙니다.

즉 심장 박동기등 어떤 장치를 몸에 삽입하였을때 그 장치를 등록하여야 한다고 되어 있습니다.

이때 그 장치에 RFID(베리칩) 같은 것을 부착하여 등록하게 하면 그 베리칩에 환자에 대한 모든 의료정보가 기록되게 되고 긴급 상황시에(환자가 의식이 없을때)  의료정보를 읽어 낼수 있게 한다는 것입니다.

그러므로 강제로 누구나 의료 혜택을 받는 사람들에게 베리칩을 주입하는 것이 아닙니다.

아직은 시대 상황이 그렇게 강제로 무엇을 할수 있을 정도로 무르 익지는 않았습니다.

만약 세계적인 전쟁이 나고 비상 사태가 나면 독재정부 적그리스도가 나타나고 베리칩 같은것으로 통제하게 될것입니다.

미국은 아직 민주 자유 국가 이기 때문에 그런 강제성은 아직 시기 상조입니다.

하지만 베리칩은 2004년에 이미 인체에 삽입할수 있도록 FDA 의 승인을 받았고 여러분야에 적용하도록 전 세계적으로 로비활동을 강화하고 있습니다.

일전에 제가 블로그를 통하여 급한 김에 강제적으로

베리칩을 삽입하는 것으로 긁을 읽으시는 분들에게 잘못 인식하게 한것을

사과 드립니다.

현재의 베리칩은 사실 그 크기가 너무 큰 상태입니다.

막말로 수술하여 빼내 버리면 그만입니다.

베리칩은 앞으로 더 많이 발전해야 할 것입니다.

소형화 되고 자체로 에너지를 발생하며 전파를 발생하는,

더 많은 데이타는 저장할수 있는 장치로 발전 될것입니다.

나가서 신경 세포와 소통이 가능한 슈퍼칩으로 발전할수도 있습니다.

하여간 이런 모든 종말의 징조들이 하나의 목표를 향하여 가고 있다는 사실은 분명합니다.

그것은  세계적인 독재정부의 등장 적그리스도의 등장입니다.

skydrive 에 있는 종말론 세미나 자료를 참조하시기 바랍니다.

 

http://cid-35a8aa5fd795b348.office.live.com/browse.aspx/%eb%ac%b8%ec%84%9c

 

 

주님을 찬양합니다.

주님을 사모합니다.

마라나타!

 

<HR 3200문서>

‘‘National Medical Device Registry”

9 ‘‘(g)(1) The Secretary shall establish a national med10

ical device registry (in this subsection referred to as the ‘reg11

istry’) to facilitate analysis of postmarket safety and out12

comes data on each device that—

13 ‘‘(A) is or has been used in or on a patient; and

14 ‘‘(B) is—

15 ‘‘(i) a class III device; or

16 ‘‘(ii) a class II device that is implantable,

17 life-supporting, or life-sustaining.

18 ‘‘(2) In developing the registry, the Secretary shall, in

19 consultation with the Commissioner of Food and Drugs, the

20 Administrator of the Centers for Medicare & Medicaid Serv21

ices, the head of the Office of the National Coordinator for

22 Health Information Technology, and the Secretary of Vet

-----------------------------------------------------------------------------------------

<FDA 승인문서>

<TYPE>EX-99.2

<SEQUENCE>3

<FILENAME>ex99p2.txt

<TEXT>

<PAGE>

 

                                                                  Exhibit 99.2

 

[SEAL] DEPARTMENT OF HEALTH & HUMAN SERVICES      Public Health Service

 

------------------------------------------------------------------------------

 

                                                  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

 

 

</TEXT>

</DOCUMENT>