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Thread: Mark of the Beast - The Subdermal Microchip

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    Exclamation Mark of the Beast - The Subdermal Microchip

    .

    The Mark of the Beast - The Subdermal Microchip

    http://www.call2holiness.org/Markoft...ftheBeast.html


    .
    "At that time there shall arise Michael, the great prince, guardian of your people; It shall be a time unsurpassed in distress since nations began until that time." (Dn 12:1)

    www.call2holiness.org/iniquity.htm

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    Warning From Man Who Designed RFID Microchip
    010319

    Carl Sanders sat in seventeen New World Order meetings with heads-of-state officials such as Henry Kissinger and Bob Gates of the C.I.A. to discuss plans on how to bring about this one-world system. The government commissioned Carl Sanders to design a microchip for identifying and controlling the peoples of the world—a microchip that could be inserted under the skin with a hypodermic needle (a quick, convenient method that would be gradually accepted by society).

    Carl Sanders, with a team of engineers behind him, with U.S. grant monies supplied by tax dollars, took on this project and designed a microchip that is powered by a lithium battery, rechargeable through the temperature changes in our skin. Without the knowledge of the Bible (Brother Sanders was not a Christian at the time), these engineers spent one-and-a-half-million dollars doing research on the best and most convenient place to have the microchip inserted.

    Guess what? These researchers found that the forehead and the back of the hand is not just the most convenient place, but is also the only viable place for rapid, consistent temperature changes in the skin to recharge the lithium battery. The microchip is approximately seven millimetres in length, .75 millimetres in diameter, about the size of a grain of rice. It is capable of storing pages upon pages of information about you. All your general history, work history, crime record, health history, and financial data can be stored on this chip.

    Brother Sanders believes that this microchip, which he regretfully helped design, is the “mark” spoken about in Revelation 13:15–17. The original Greek word for “mark” is “charagma,” which means a “scratch or etching.” It is also interesting to note that the number 666 is actually a word in the original Greek. The word is “chi xi stigma,” with the last part, “stigma,” also meaning “to stick or prick.”

    .


    https://www.youtube.com/watch?v=nuv6IyQDjME
    "At that time there shall arise Michael, the great prince, guardian of your people; It shall be a time unsurpassed in distress since nations began until that time." (Dn 12:1)

    www.call2holiness.org/iniquity.htm

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    Mark 7:14-16
    14 And when he had called all the people unto him, he said unto them, Hearken unto me every one of you, and understand:
    15 There is nothing from without a man, that entering into him can defile him: but the things which come out of him, those are they that defile the man.
    16 If any man have ears to hear, let him hear. (KJV)

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    Mar 7:6 He said to them, 'Isaiah prophesied rightly about you hypocrites, as it is written, "This people honours me with their lips, but their hearts are far from me;
    Mar 7:7 in vain do they worship me, teaching human precepts as doctrines."
    Mar 7:8 You abandon the commandment of God and hold to human tradition.'
    Mar 7:9 Then he said to them, 'You have a fine way of rejecting the commandment of God in order to keep your tradition!
    Mar 7:10 For Moses said, "Honour your father and your mother"; and, "Whoever speaks evil of father or mother must surely die."
    Mar 7:11 But you say that if anyone tells father or mother, "Whatever support you might have had from me is Corban" (that is, an offering to God)--
    Mar 7:12 then you no longer permit doing anything for a father or mother,
    Mar 7:13 thus making void the word of God through your tradition that you have handed on. And you do many things like this.'
    Mar 7:14 Then he called the crowd again and said to them, 'Listen to me, all of you, and understand:
    Mar 7:15 there is nothing outside a person that by going in can defile, but the things that come out are what defile.'
    Mar 7:17 When he had left the crowd and entered the house, his disciples asked him about the parable.
    Mar 7:18 He said to them, 'Then do you also fail to understand? Do you not see that whatever goes into a person from outside cannot defile,
    Mar 7:19 since it enters, not the heart but the stomach, and goes out into the sewer?' (Thus he declared all foods clean.)
    .



    Mark of the Beast - The Subdermal Microchip





    .
    "At that time there shall arise Michael, the great prince, guardian of your people; It shall be a time unsurpassed in distress since nations began until that time." (Dn 12:1)

    www.call2holiness.org/iniquity.htm

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    John 6:47-51
    47 I tell you the truth, he who believes has everlasting life.
    48 I am the bread of life.
    49 Your forefathers ate the manna in the desert, yet they died.
    50 But here is the bread that comes down from heaven, which a man may eat and not die.
    51 I am the living bread that came down from heaven. If anyone eats of this bread, he will live forever. This bread is my flesh, which I will give for the life of the world."
    52 Then the Jews began to argue sharply among themselves, "How can this man give us his flesh to eat?"
    53 Jesus said to them, "I tell you the truth, unless you eat the flesh of the Son of Man and drink his blood, you have no life in you.
    54 Whoever eats my flesh and drinks my blood has eternal life, and I will raise him up at the last day.
    55 For my flesh is real food and my blood is real drink.
    56 Whoever eats my flesh and drinks my blood remains in me, and I in him.

    Are Christians then to be cannibals and vampires?


    Rom 8:
    38 For I am persuaded that neither death nor life, nor angels nor principalities nor powers, nor things present nor things to come,
    39 nor height nor depth, nor any other created thing, shall be able to separate us from the love of God which is in Christ
    39 nor height nor depth, NOR ANY OTHER CREATED THING, shall be able to separate us from the love of God which is in Christ Jesus our Lord.

    Simply Because He Said So….

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    Watchman,

    What do these arbitrary and isolated citations taken out of context have to do with the Mark of the Beast? Must I continue to guess? What is your point?

    Text taken out of context is a pretext.

    Start another thread(s) on whatever point you are attempting to make, and I will teach you the truth.....assuming that you believe and follow Holy Scripture:

    1Ti 2:3 This is right and is acceptable in the sight of God our Saviour,
    1Ti 2:4 who desires everyone to be saved and to come to the knowledge of the truth.

    1Ti 3:14 I hope to come to you soon, but I am writing these instructions to you so that,
    1Ti 3:15 if I am delayed, you may know how one ought to behave in the household of God, which is the church of the living God, the pillar and bulwark of the truth.

    Note: It does not say that the KJV book is the pillar and bulwark of truth.....nor the Holy Bible....but the Church that wrote, defined and compiled the Holy Bible. Even the founder of your belief system held that to be true:

    According to Martin Luther:
    Page 265 reads: "...Accordingly, we concede to the papacy that they sit in the true Church, possessing the office instituted by Christ and inherited from the apostles, to teach, baptize, administer the sacrament, absolve, ordain, etc., just as the Jews sat in their synagogues or assemblies and were the regularly established priesthood and authority of the Church. We admit all this and do not attack the office, although they are not willing to admit as much for us; yea, we confess that we have received these things from them, even as Christ by birth descended from the Jews and the apostles obtained the Scriptures from them..." Luther's Sermon for the Sunday after Christ’s Ascension; John 15:26-16:4 (2nd sermon), page 265, paragraph 28, 1522

    http://www.trinitylutheranms.org/Mar...15_26_2nd.html

    Once again, if you are truly a bibleiver...and seek the truth, I will be glad to assist to the extent that I can, but spare me the copying and pasting arbitrary and isolated citations without meaningful dialogue and expecting me to guess at your point. Your wasting your time....and proving nothing.

    Defend you belief system, if you can. If it has legs it should be able to stand on its own. No where within Holy Scripture....or even the KJV book, does it provide man the authorization to start his own "church", if he finds anything in the Church of Jesus Christ that he does not like.

    I await your new threads.....but please do not attempt to hijack this one with plastered inapplicable citations.
    "At that time there shall arise Michael, the great prince, guardian of your people; It shall be a time unsurpassed in distress since nations began until that time." (Dn 12:1)

    www.call2holiness.org/iniquity.htm

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    .
    World Economic Forum Debuts Framework For Central Bank Digital Currency

    by Tyler Durden
    Thu, 01/23/2020 - 12:47
    Authored by Adrian Zmudzinksi via CoinTelegraph.com,

    The World Economic Forum (WEF) - together with some of the world's major central banks - has created a central bank digital currency (CBDC) policymaker toolkit.


    According to an announcement on Jan. 22, the toolkit is the WEF's attempt to help policy-makers understand whether deploying a CBDC would be advantageous and guide them through its design.


    The WEF collaborated with regulators, central bank researchers, international organizations and experts from over 40 institutions to develop the framework. The head of blockchain and distributed ledger technology (DLT) at the World Economic Forum Sheila Warren explained:


    “Given the critical roles central banks play in the global economy, any central bank digital currency implementation, including potentially with blockchain technology, will have a profound impact domestically and internationally.

    [...]

    It is imperative that central banks proceed cautiously, with a rigorous analysis of the opportunities and challenges posed
    .”

    Bank of Thailand Governor Veerathai Santiprabhob said that the institution made good progress on its own CBDC implementation, called Project Inthanon. Recently, reports started circulating that Hong Kong and Thailand’s central banks have stepped closer to implementing a joint CBDC for cross-border payments. He explained how the toolkit is useful for the continued development of the bank’s digital currency:


    “From our experience, we need to identify tradeoffs between benefits from the use cases and their associated risks across different dimensions. This is where the Policymaker Toolkit could usefully provide an actionable framework for CBDC deployment.”


    Central Bank of Bahrain Governor Rasheed M. Al Maraj announced that the institution that he is guiding will pilot the WEF’s toolkit, saying, “We hope that it will be an opportunity to learn, grow and to adapt to the changes in the Fourth Industrial Revolution.”


    The pros and cons of a digital currency


    The framework recognizes that a CBDC — among other things — can improve the cost and speed efficiencies of cross-border interbank payments, as well as reduce settlement and counterparty risks. The WEF notes that a digital currency can also enhance financial data transmission and reporting, and improve traceability compared to physical cash.


    The paper admits that, before considering a CBDC, other solutions to economic friction should be considered. A digital currency may not add value in domestic interbank payments where an efficient system is already present.

    The toolkit also notes that digital currency implementation requires substantial investments in cybersecurity and system resilience, and that potential risks come along with it:

    Generates substantial financial risks, including: 1) bank disintermediation risk, which could reduce bank profits and lending activity; 2) digital
    bankrun risk as depositors may rapidly convert commercial bank deposits to CBDC.”

    Toolkit distinguishes between different types of CBDCs


    The WEF’s framework divides CBDCs into three categories: retail, wholesale and hybrid. The first category allows non-financial users to hold digital currency accounts, while the second is an electronic system granting access to the central bank reserve that could be used by commercial banks and other financial institutions for interbank and security transactions.


    Hybrid CBDCs allow financial institutions that do not usually have access to a central bank deposit facility to hold reserves at it. This would enable stronger safeguards and monitoring of those organizations and improve interoperability between different payment systems, according to the WEF.


    The paper explains that in the case of a DLT-based CBDC, the central bank would preserve full control over the issuance of the digital currency:


    “[The central bank] could delegate transaction approval to a more decentralized network, most likely consisting of regulated financial institutions. Transaction approval could follow a pre
    specified consensus process determined by the central bank, which could include privileges for the central bank such as transaction ‘veto’ powers or visibility. It is also possible to develop a DLT system in which the central bank remains the only validating node yet it benefits from other advantages related to DLT.”

    The impact of stablecoins on CBDC development


    Global efforts and discussions around CBDC development are increasingly common. Many believe that stablecoins — and Facebook’s Libra in particular — served as a wake-up call for central banks to realize that in the digital age the public expects cheap and instant digital payments.


    Earlier this month, the president of the European Central Bank, Christine Lagarde, also said that she supports the bank’s active involvement in the development of a CBDC, particularly in addressing the demand for faster and cheaper cross-border payments.


    https://www.zerohedge.com/crypto/wor...gital-currency
    https://cointelegraph.com/news/world...gital-currency


    Cash, Plastic or Hand? Amazon Envisions Paying With a Wave
    Tech giant plans terminals to let consumers link credit card information to their hands

    https://tinyurl.com/umkwr29




    John Leary (yet to be approved)

    August 22, 2016:
    Jesus said: “My people, I am showing you a rich looking hotel where the G-8 people were meeting in secret. They were making plans how to crash the dollar, and replace it with a gold backed currency called SDRs or Special Drawing Rights. This will be an electronic currency that would require chips in the body to complete any transaction. A gold backed currency would attract more investors, and soon the debt backed dollar would become worthless. Many rich people are already using their dollars to purchase value assets that keep their value like gold, silver, diamonds, artwork, and land. When the dollar crashes, all dollar backed assets would also become worthless. Your markets would crash and your stores would be cleaned out by thieves. Such a major event would cause riots in the streets, and precipitate a martial law. If you see the banks close and the dollar lose its value, then it will be time to come to the safety of My refuges. Many will lose what money they have in bankruptcy, but the rich and those people who have value assets, will not lose anything. See this coming martial law as another reason to be ready to leave for My refuges.”





    The Mark of the Beast - The Subdermal Microchip
    www.call2holiness.org/MarkoftheBeast/MarkoftheBeast.html

    "At that time there shall arise Michael, the great prince, guardian of your people; It shall be a time unsurpassed in distress since nations began until that time." (Dn 12:1)

    www.call2holiness.org/iniquity.htm

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    In the USA, the Affordable Healthcare Act -- aka Obamacare -- nationalizing health care provides for the Mark of the Beast. Heaven advised that once an uncommon fear is established.....via war, plague, famine.....healthcare will be denied to those who do no accept the Chip. The applicable verbiage lies within the Act that reconciled the Senate Bills and House Bills:


    H.R. 4872 – Health Care and Education Affordibility Reconcilation Act of 2010.



    Subtitle C--National Medical Device RegistryCommentsClose CommentsPermalink

    SEC. 2521. NATIONAL MEDICAL DEVICE REGISTRY.
    (a) Registry-CommentsClose CommentsPermalink


    (1) IN GENERAL- Section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is amended--CommentsClose CommentsPermalink


    (A) by redesignating subsection (g) as subsection (h); andCommentsClose CommentsPermalink


    (B) by inserting after subsection (f) the following:CommentsClose CommentsPermalink


    ‘National Medical Device Registry
    ‘(g)(1) The Secretary shall establish a national medical device registry (in this subsection referred to as the ‘registry’) to facilitate analysis of postmarket safety and outcomes data on each device that--CommentsClose CommentsPermalink



    ‘(A) is or has been used in or on a patient; andCommentsClose CommentsPermalink


    ‘(B) is--CommentsClose CommentsPermalink


    ‘(i) a class III device; orCommentsClose CommentsPermalink



    ‘(ii) a class II device that is implantable, life-supporting, or life-sustaining.CommentsClose CommentsPermalink


    ‘(2) In developing the registry, the Secretary shall, in consultation with the Commissioner of Food and Drugs, the Administrator of the Centers for Medicare & Medicaid Services, the head of the Office of the National Coordinator for Health Information Technology, and the Secretary of Veterans Affairs, determine the best methods for--CommentsClose CommentsPermalink


    ‘(A) including in the registry, in a manner consistent with subsection (f), appropriate information to identify each device described in paragraph (1) by type, model, and serial number or other unique identifier;CommentsClose CommentsPermalink


    ‘(B) validating methods for analyzing patient safety and outcomes data from multiple sources and for linking such data with the information included in the registry as described in subparagraph (A), including, to the extent feasible, use of--CommentsClose CommentsPermalink


    ‘(i) data provided to the Secretary under other provisions of this chapter; andCommentsClose CommentsPermalink


    ‘(ii) information from public and private sources identified under paragraph (3);CommentsClose CommentsPermalink


    ‘(C) integrating the activities described in this subsection with--CommentsClose CommentsPermalink


    ‘(i) activities under paragraph (3) of section 505(k) (relating to active postmarket risk identification);CommentsClose CommentsPermalink


    ‘(ii) activities under paragraph (4) of section 505(k) (relating to advanced analysis of drug safety data); andCommentsClose CommentsPermalink


    ‘(iii) other postmarket device surveillance activities of the Secretary authorized by this chapter; andCommentsClose CommentsPermalink


    ‘(D) providing public access to the data and analysis collected or developed through the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scientists.CommentsClose CommentsPermalink


    ‘(3)(A) To facilitate analyses of postmarket safety and patient outcomes for devices described in paragraph (1), the Secretary shall, in collaboration with public, academic, and private entities, develop methods to--CommentsClose CommentsPermalink


    ‘(i) obtain access to disparate sources of patient safety and outcomes data, including--CommentsClose CommentsPermalink

    ‘(I) Federal health-related electronic data (such as data from the Medicare program under title XVIII of the Social Security Act or from the health systems of the Department of Veterans Affairs);CommentsClose CommentsPermalink


    ‘(II) private sector health-related electronic data (such as pharmaceutical purchase data and health insurance claims data); andCommentsClose CommentsPermalink


    ‘(III) other data as the Secretary deems necessary to permit postmarket assessment of device safety and effectiveness; andCommentsClose CommentsPermalink


    ‘(ii) link data obtained under clause (i) with information in the registry.CommentsClose CommentsPermalink


    ‘(B) In this paragraph, the term ‘data’ refers to information respecting a device described in paragraph (1), including claims data, patient survey data, standardized analytic files that allow for the pooling and analysis of data from disparate data environments, electronic health records, and any other data deemed appropriate by the Secretary.CommentsClose CommentsPermalink


    ‘(4) Not later than 36 months after the date of the enactment of this subsection, the Secretary shall promulgate regulations for establishment and operation of the registry under paragraph (1). Such regulations--CommentsClose CommentsPermalink


    ‘(A)(i) in the case of devices that are described in paragraph (1) and sold on or after the date of the enactment of this subsection, shall require manufacturers of such devices to submit information to the registry, including, for each such device, the type, model, and serial number or, if required under subsection (f), other unique device identifier; andCommentsClose CommentsPermalink


    ‘(ii) in the case of devices that are described in paragraph (1) and sold before such date, may require manufacturers of such devices to submit such information to the registry, if deemed necessary by the Secretary to protect the public health;CommentsClose CommentsPermalink


    ‘(B) shall establish procedures--CommentsClose CommentsPermalink


    ‘(i) to permit linkage of information submitted pursuant to subparagraph (A) with patient safety and outcomes data obtained under paragraph (3); andCommentsClose CommentsPermalink


    ‘(ii) to permit analyses of linked data;CommentsClose CommentsPermalink


    ‘(C) may require device manufacturers to submit such other information as is necessary to facilitate postmarket assessments of device safety and effectiveness and notification of device risks;CommentsClose CommentsPermalink


    ‘(D) shall establish requirements for regular and timely reports to the Secretary, which shall be included in the registry, concerning adverse event trends, adverse event patterns, incidence and prevalence of adverse events, and other information the Secretary determines appropriate, which may include data on comparative safety and outcomes trends; andCommentsClose CommentsPermalink


    ‘(E) shall establish procedures to permit public access to the information in the registry in a manner and form that protects patient privacy and proprietary information and is comprehensive, useful, and not misleading to patients, physicians, and scientists.CommentsClose CommentsPermalink


    ‘(5) To carry out this subsection, there are authorized to be appropriated such sums as may be necessary for fiscal years 2010 and 2011.’.CommentsClose CommentsPermalink


    (2) EFFECTIVE DATE- The Secretary of Health and Human Services shall establish and begin implementation of the registry under section 519(g) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph (1), by not later than the date that is 36 months after the date of the enactment of this Act, without regard to whether or not final regulations to establish and operate the registry have been promulgated by such date.CommentsClose CommentsPermalink


    (3) CONFORMING AMENDMENT- Section 303(f)(


    Source:
    http://www.opencongress.org/bill/111-h4872/text?version=rh&nid=t0:rh:13783




    "At that time there shall arise Michael, the great prince, guardian of your people; It shall be a time unsurpassed in distress since nations began until that time." (Dn 12:1)

    www.call2holiness.org/iniquity.htm

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    GUIDANCE DOCUMENT


    Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information - Guidance for Industry and FDA Staff December 2004

    Final



    Issued by:
    Office of Medical Products and Tobacco, Center for Devices and Radiological Health
    Document issued on: December 10, 2004



    For questions regarding the use or interpretation of this guidance contact: Gail Gantt at 301-796-6288 or by email gail.gantt@fda.hhs.gov.
    [IMG]file:///C:\Users\Ben\AppData\Local\Temp\msohtmlclip1\01\cl ip_image001.gif[/IMG]

    U.S. Department of Health and Human Services
    Food and Drug Administration

    Center for Devices and Radiological Health

    General Hospital DevicesBranch
    Division of Anesthesiology, General Hospital,
    Infection Control and Dental Devices
    Office of Device Evaluation


    Preface


    Public Comment

    Written comments and suggestions may be submitted at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. Alternatively, e lectronic comments may be submitted to Regulations.gov. Please identify your comments with the docket number listed in the notice of availability that publishes in the Federal Register announcing the availability of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
    Additional Copies
    Additional copies are available from the Internet. You may also send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number (1541) to identify the guidance you are requesting.
    Table of Contents

    1. BACKGROUND
    2. SCOPE
    3. RISKS TO HEALTH
    4. RECOMMENDED MITIGATION MEASURES
      1. BIOCOMPATIBILITY
      2. INFORMATION SECURITY PROCEDURES (DESIGN AND VALIDATION)
      3. SOFTWARE VALIDATION
      4. MIGRATION TESTING OF IMPLANTED TRANSPONDER
      5. PERFORMANCE TESTING OF IMPLANTED TRANSPONDER
      6. PERFORMANCE TESTING OF INSERTER
      7. PERFORMANCE TESTING AND HAZARD ANALYSIS OF ELECTRONIC SCANNER
      8. ELECTROMAGNETIC COMPATIBILITY
      9. ELECTRICAL SAFETY PERFORMANCE TESTING
      10. STERILITY
      11. MAGNETIC RESONANCE IMAGING COMPATIBILITY
      12. LABELING

    5. LIMITATIONS OF EXEMPTION FROM PREMARKET NOTIFICATION


    Guidance for Industry and FDA Staff

    Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information


    1. Background

    This guidance document was developed as a special control guidance to support the classification of the implantable radiofrequency transponder system for patient identification and health information into class II (special controls). The device is intended to enable access to secure patient identification and corresponding health information in humans. This guidance is issued in conjunction with a Federal Register notice announcing the classification of implantable radiofrequency transponder system for patient identification and health information.
    This guidance document describes a means by which implantable radiofrequency transponder systems for patient identification and health information may comply with the requirement of class II special controls. Designation of this guidance document as a special control means that manufacturers of implantable radiofrequency transponder systems for patient identification and health information who follow the recommendations listed in this document, before introducing their device into commercial distribution in the United States, will also be able to market their device without being subject to the premarket notification requirements of section 510(k) of the Act.
    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 this generic type of device if the manufacturer follows the recommendations in this special controls guidance or equivalent measures to address the risks identified in this guidance. Thus, persons who intend to market a device of this type do not need to submit a premarket notification to FDA and receive agency clearance prior to marketing the device, but as a class II device, the device must comply with the other applicable general and special controls (Section 513(a)(1)(B)).
    Following the effective date of a final rule exempting the device, manufacturers of implantable radiofrequency transponder systems for patient identification and health information will need to address the issues covered in this special control guidance. The firm must show that its device addresses the issues of safety and effectiveness identified in this guidance, either by meeting the recommendations of this guidance or by some other means that provides equivalent assurances of safety and effectiveness.
    The Least Burdensome Approach
    The issues identified in this guidance document represent those that we believe need to be addressed before your device can be marketed. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. We also considered the burden that may be incurred in your attempt to follow the statutory and regulatory criteria in the manner suggested by the guidance and in your attempt to address the issues we have identified.1 We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. If, however, you believe that there is a less burdensome way to address the issues, you should follow the procedures outlined in the “A Suggested Approach to Resolving Least Burdensome Issues” document.
    1 We recommend that you document how you have addressed the recommendations in your design history file. Manufacturers must maintain design controls, including a design history file, in accordance with 21 CFR 820.30.
    [IMG]file:///C:\Users\Ben\AppData\Local\Temp\msohtmlclip1\01\cl ip_image002.gif[/IMG]

    2. Scope
    The scope of this document is limited to the following device as described in 21 CFR 880.6300 Implantable Radiofrequency Transponder System for Patient Identification and Health Information (product code: NRV):
    An implantable radiofrequency transponder system for patient identification and health information is a device 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.
    [IMG]file:///C:\Users\Ben\AppData\Local\Temp\msohtmlclip1\01\cl ip_image002.gif[/IMG]

    3. Risks to Health
    In the table below, FDA has identified the risks to health generally associated with the use of the Implantable Radiofrequency Transponder System for Patient Identification and Health Information addressed in this document. FDA recommends the following measures to mitigate the identified risks in this guidance, as shown in the table below.
    Identified risk
    Recommended mitigation measures
    (See the corresponding subheading in section 4)
    Adverse Tissue Reaction A. Biocompatibility
    J.
    Sterility
    L.
    Labeling
    Migration of implanted transponder D. Migration Testing of Implanted Transponder
    Compromised Information Security B. Information Security Procedures (Design and Validation)
    Failure of implanted transponder E. Performance Testing of Implanted Transponder
    L.
    Labeling
    Failure of Inserter F. Performance Testing of Inserter
    Failure of electronic scanner G. Performance Testing and Hazard Analysis of Electronic Scanner
    C.
    Software Validation
    L.
    Labeling
    Electromagnetic Interference H. Electromagnetic compatibility
    L.
    Labeling
    Electrical Hazards I. Electrical Safety performance testing
    L.
    Labeling
    Magnetic Resonance Imaging Incompatibility K. Magnetic Resonance Imaging Compatibility
    L.
    Labeling
    Needle stick L. Labeling
    [IMG]file:///C:\Users\Ben\AppData\Local\Temp\msohtmlclip1\01\cl ip_image002.gif[/IMG]

    4. Recommended Mitigation Measures
    FDA believes that conformance with this guidance document, when combined with the general controls of the Act, will provided reasonable assurance of the safety and effectiveness of the implantable radiofrequency transponder system for patient identification and health information . We recommend that you (the manufacturer) evaluate your device as described below and, where appropriate, document the results in your design history file as a part of the Quality Systems Requirements (21 CFR 820.30).
    A. Biocompatibility
    We recommend that you ensure the biocompatibility of the patient-contacting parts of your device by following the tests in the:

    • International Standard Organization (ISO) standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.

    B. Information Security Procedures (Design and Validation)
    When discussing the issue of medical devices that store, access, and/or transfer information externally, you should address the concept of information security. Information security is the process of preventing the modification, misuse or denial of use, or the unauthorized use of that information. We recommend that your specifications for a compatible database address the following four components of information security: Confidentiality, Integrity, Availability, and Accountability (CIAA).

    • Confidentiality means the characteristic of data and information being disclosed only to authorized persons, entities and processes at authorized times and in the authorized manner. (The assurance that no unauthorized users have access to the information.)
    • Integrity means the characteristic of data and information being accurate and complete and the preservation of accuracy and completeness. (The assurance that the information is correct (accurate and complete) - that is, it has not been improperly modified.)
    • Availability means the characteristic of data, information and information systems being accessible and usable on a timely basis in the required manner. (The assurance that the information will be available when needed.)
    • Accountability is the application of identification and authentication to assure that the prescribed access process is being done by an authorized user.

    C. Software Validation
    We recommend that you validate the software in your device by referring to the following guidance:


    D. Migration Testing of Implanted Transponder
    We recommend that you conduct testing of the implanted transponder to demonstrate that the transponder will not migrate after implantation.
    E. Performance Testing of Implanted Transponder
    We recommend that you conduct testing of the transponder that will demonstrate that under conditions of use the transponder sends an identification (ID) code and that the ID code is correct. The testing should address loss or corruption of the data, latency and through-put, and be coordinated with the electromagnetic compatibility (EMC) performance of the implant, scanner and wireless data link.
    F. Performance Testing of Inserter
    We recommend that you demonstrate the functionality of the insertion device by conducting testing that demonstrates that inserter can properly implant the transponder.
    G. Performance Testing and Hazard Analysis of Electronic Scanner
    We recommend that you address the functionality of the electronic scanner by conducting performance testing and hazard analysis that demonstrate the scanner utility in reading the transponder identification code.
    H. Electromagnetic Compatibility
    We recommend that you demonstrate the basic EMC of the device (i.e., transponder and scanner together) by performing EMC testing in accordance with the following FDA- recognized standard:

    • IEC 60601-1-2 (Second Edition, 2001) Medical electrical equipment - Part1: General requirements for safety; Electromagnetic compatibility - Requirements and Tests, or its equivalent.

    I. Electrical Safety Performance Testing
    We recommend that you demonstrate the electrical safety of your device by following the testing in:

    • IEC 60601-1, Medical Electrical Equipment – Part 1: General Requirements for Safety

    J. Sterility
    We recommend that the transponder and inserter be sterile with a sterility assurance level of 10 -6. We also recommend that you address the sterility of your device by reviewing the following:


    K. Magnetic Resonance Imaging Compatibility
    We recommend that you demonstrate the magnetic resonance imaging compatibility of your device by following:

    • ASTM F2052-02 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
    • ASTM F2182-02a Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging
    • ASTM F2213-04 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
    • ASTM F2119-01 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.

    In addition, you should also address the EMC concerns for implant exposure to the significant magnetic and radiofrequency emissions from MRI, including concerns for implant malfunction or damage from MRI exposure and the use of the scanner during MRI procedures.
    L. Labeling
    As a prescription device, under 21 CFR 801.109, the device is exempt from having adequate directions for lay use.2
    We recommend that instructions delineate the technological features of the specific device and how the device is to be used on patients. We recommend that the instructions encourage local/institutional training programs designed to familiarize users with the features of the device and how to use it in a safe and effective manner. If there are any precautions or warnings, which relate to packaging or sterility, these should be repeated on the package labels.
    We also recommend that you provide after surgery care instructions to the patient. See also Guidance on Medical Device Patient Labeling.
    2Final labeling must comply with the requirements of 21 CFR 801 before a medical device is introduced into interstate commerce.
    [IMG]file:///C:\Users\Ben\AppData\Local\Temp\msohtmlclip1\01\cl ip_image002.gif[/IMG]

    5. Limitations of Exemption from Premarket Notification
    FDA's decision to exempt a Class II device from the requirement of premarket notification is based on the existing and reasonably foreseeable characteristics of devices within that generic type that currently are, or have been, in commercial distribution. Section 21 CFR 880.9 specifies the limitations to exemption. If any of these limitations apply, your device is not exempt and you must submit a premarket notification.
    https://www.fda.gov/regulatory-infor...system-patient
    "At that time there shall arise Michael, the great prince, guardian of your people; It shall be a time unsurpassed in distress since nations began until that time." (Dn 12:1)

    www.call2holiness.org/iniquity.htm

  10. #10
    Join Date
    Dec 2007
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    …...A Sin that Will Not Be Forgiven...

    "And another angel, a third, followed them, saying with a loud voice,
    "If any one worships the beast and its image, and receives a mark on his forehead or on his hand, he also shall drink the wine of God's wrath, poured unmixed into the cup of his anger, and he shall be tormented with fire and sulphur in the presence of the holy angels and in the presence of the Lamb. And the smoke of their torment goes up for ever and ever; and they have no rest, day or night, these worshipers of the beast and its image, and whoever receives the mark of its name." (Rv 14:9-11)

    As we see from the citation above, anyone who willingly accepts the subdermal microchip placed in their body will go to Hell irrevocably upon his death.
    Willful acceptance of the markof the Beast constitutes a sin that will NOT be forgiven. That is because by doing so, one loses his free will and ability to seek forgiveness.

    "At that time there shall arise Michael, the great prince, guardian of your people; It shall be a time unsurpassed in distress since nations began until that time." (Dn 12:1)

    www.call2holiness.org/iniquity.htm

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