Issued by US FDA on 10 December 2004: Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information

Hello, John and Doves,

Guess when the Mark of the Beast was detailed.

Would you believe that on December 10, 2004 the U.S. Food and Drug Administration published a

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

However, it is written,

Many plans are in a man's heart, But the counsel of the LORD will stand.

Proverbs 19:21 NAS

Again, it is written,

8“Do not forget this! Keep it in mind!

Remember this, you guilty ones.

9Remember the things I have done in the past.

For I alone am God!

I am God, and there is none like me.

10Only I can tell you the future

before it even happens.

Everything I plan will come to pass,

for I do whatever I wish.

11I will call a swift bird of prey from the east—

a leader from a distant land to come and do my bidding.

I have said what I would do,

and I will do it.

12“Listen to me, you stubborn people

who are so far from doing right.

13For I am ready to set things right,

not in the distant future, but right now!

I am ready to save Jerusalem^a

and show my glory to Israel.

Isaiah 46:1-13 NLT

And yet, we remember that Yeshua said,

Jesus said unto them, Verily, verily, I say unto you, Before Abraham was, I am.

John 8:58 KJV

And I would be remiss in my duty, indeed, if I did not mention the following verses.

First off, we fast forward to the end of Daniel’s 70^th week [Yom Kippur 5776, imho] and we read,

The Lamb and the 144,000

1Then I saw the Lamb standing on Mount Zion, and with him were 144,000 who had his name and his Father’s name written on their foreheads. 2And I heard a sound from heaven like the roar of mighty ocean waves or the rolling of loud thunder. It was like the sound of many harpists playing together.

3This great choir sang a wonderful new song in front of the throne of God and before the four living beings and the twenty-four elders. No one could learn this song except the 144,000 who had been redeemed from the earth. 4They have kept themselves as pure as virgins,^a following the Lamb wherever he goes. They have been purchased from among the people on the earth as a special offering^b to God and to the Lamb. 5They have told no lies; they are without blame.

The Three Angels

6And I saw another angel flying through the sky, carrying the eternal Good News to proclaim to the people who belong to this world—to every nation, tribe, language, and people. 7“Fear God,” he shouted. “Give glory to him. For the time has come when he will sit as judge. Worship him who made the heavens, the earth, the sea, and all the springs of water.”

8Then another angel followed him through the sky, shouting, “Babylon is fallen—that great city is fallen—because she made all the nations of the world drink the wine of her passionate immorality.”

9Then a third angel followed them, shouting, “Anyone who worships the beast and his statue or who accepts his mark on the forehead or on the hand 10must drink the wine of God’s anger. It has been poured full strength into God’s cup of wrath. And they will be tormented with fire and burning sulfur in the presence of the holy angels and the Lamb. 11The smoke of their torment will rise forever and ever, and they will have no relief day or night, for they have worshiped the beast and his statue and have accepted the mark of his name.”

12This means that God’s holy people must endure persecution patiently, obeying his commands and maintaining their faith in Jesus.

13And I heard a voice from heaven saying, “Write this down: Blessed are those who die in the Lord from now on. Yes, says the Spirit, they are blessed indeed, for they will rest from their hard work; for their good deeds follow them!”

Revelation 14:1-13 NLT

We know that we are at the end of Daniel’s Seventieth Week, because the rest of Revelation chapter 14 talks of Sukkot—the time of the traditional grape harvest in Israel.

http://www.jpost.com/Arts-and-Culture/Food-And-Wine/Wine-Talk-Harvest-time

And so we read,

The Harvest of the Earth

14Then I saw a white cloud, and seated on the cloud was someone like the Son of Man.^c He had a gold crown on his head and a sharp sickle in his hand.

15Then another angel came from the Temple and shouted to the one sitting on the cloud, “Swing the sickle, for the time of harvest has come; the crop on earth is ripe.” 16So the one sitting on the cloud swung his sickle over the earth, and the whole earth was harvested.

17After that, another angel came from the Temple in heaven, and he also had a sharp sickle. 18Then another angel, who had power to destroy with fire, came from the altar. He shouted to the angel with the sharp sickle, “Swing your sickle now to gather the clusters of grapes from the vines of the earth, for they are ripe for judgment.” 19So the angel swung his sickle over the earth and loaded the grapes into the great winepress of God’s wrath. 20The grapes were trampled in the winepress outside the city, and blood flowed from the winepress in a stream about 180 miles^d long and as high as a horse’s bridle.

Revelation 14:14-20 NLT

This passage seems to suggest that the Rapture won’t happen until just days before Christ’s Second Coming.

If there is a two-tier Rapture, then the first Rapture would happen this Rosh Hashanah?

Wednesday evening, 24 September 2014, to Thursday evening, 25 September 2014 is Rosh Hashanah 5775—the seventh Shmita year of the current cycle. 5776 marks the 70^th Jubilee since the Israelites began wandering in the eastern part of Eretz Israel—the entire Arabian peninsula!

It is written,

So the first angel went and poured out his bowl on the earth, and harmful and painful sores came upon the people who bore the mark of the beast and worshiped its image.

Revelation 16:2 ESV

Interestingly enough, the image of the first beast is, in a way, embodied in the ring he wears.

http://www.wnd.com/2012/10/obamas-ring-there-is-no-god-but-allah/

That ring has writing plus the image of a snake.

Compare the meaning of antichrist—“instead of [God’s] anointed [who is Yeshua HaMashiach]”—with these two passages: Numbers 21:4-9 and John 3:10-17.

Again, it is written,

12Then the sixth angel poured out his bowl on the great Euphrates River, and it dried up so that the kings from the east could march their armies toward the west without hindrance. 13And I saw three evil^b spirits that looked like frogs leap from the mouths of the dragon, the beast, and the false prophet. 14They are demonic spirits who work miracles and go out to all the rulers of the world to gather them for battle against the Lord on that great judgment day of God the Almighty.

15“Look, I will come as unexpectedly as a thief! Blessed are all who are watching for me, who keep their clothing ready so they will not have to walk around naked and ashamed.”

16And the demonic spirits gathered all the rulers and their armies to a place with the Hebrew name Armageddon.^c

17Then the seventh angel poured out his bowl into the air. And a mighty shout came from the throne in the Temple, saying, “It is finished!” 18Then the thunder crashed and rolled, and lightning flashed. And a great earthquake struck—the worst since people were placed on the earth. 19The great city of Babylon split into three sections, and the cities of many nations fell into heaps of rubble. So God remembered all of Babylon’s sins, and he made her drink the cup that was filled with the wine of his fierce wrath. 20And every island disappeared, and all the mountains were leveled. 21There was a terrible hailstorm, and hailstones weighing as much as seventy-five pounds^d fell from the sky onto the people below. They cursed God because of the terrible plague of the hailstorm.

Revelation 16:12-21 NLT

In the city of New York, New York USA is the greatest concentration of Jews in a single place in the whole world.

Thus, it is written,

4Then I heard another voice calling from heaven,

“Come away from her, my people.

Do not take part in her sins,

or you will be punished with her.

5For her sins are piled as high as heaven,

and God remembers her evil deeds.

6Do to her as she has done to others.

Double her penalty^d for all her evil deeds.

She brewed a cup of terror for others,

so brew twice as much^e for her.

Revelation 18:4-6 NLT

This is what happens to the first and second beasts and the armies of those who oppose Yeshua HaMashiach.

The Rider on the White Horse

11Then I saw heaven opened, and a white horse was standing there. Its rider was named Faithful and True, for he judges fairly and wages a righteous war. 12His eyes were like flames of fire, and on his head were many crowns. A name was written on him that no one understood except himself. 13He wore a robe dipped in blood, and his title was the Word of God. 14The armies of heaven, dressed in the finest of pure white linen, followed him on white horses. 15From his mouth came a sharp sword to strike down the nations. He will rule them with an iron rod. He will release the fierce wrath of God, the Almighty, like juice flowing from a winepress. 16On his robe at his thigh^e was written this title: King of all kings and Lord of all lords.

17Then I saw an angel standing in the sun, shouting to the vultures flying high in the sky: “Come! Gather together for the great banquet God has prepared. 18Come and eat the flesh of kings, generals, and strong warriors; of horses and their riders; and of all humanity, both free and slave, small and great.”

19Then I saw the beast and the kings of the world and their armies gathered together to fight against the one sitting on the horse and his army. 20And the beast was captured, and with him the false prophet who did mighty miracles on behalf of the beast—miracles that deceived all who had accepted the mark of the beast and who worshiped his statue. Both the beast and his false prophet were thrown alive into the fiery lake of burning sulfur. 21Their entire army was killed by the sharp sword that came from the mouth of the one riding the white horse. And the vultures all gorged themselves on the dead bodies.

Revelation 19:11-21 NLT

Finally, we read,

Jesus Is Coming

7“Look, I am coming soon! Blessed are those who obey the words of prophecy written in this book.^d”

8I, John, am the one who heard and saw all these things. And when I heard and saw them, I fell down to worship at the feet of the angel who showed them to me. 9But he said, “No, don’t worship me. I am a servant of God, just like you and your brothers the prophets, as well as all who obey what is written in this book. Worship only God!”

10Then he instructed me, “Do not seal up the prophetic words in this book, for the time is near. 11Let the one who is doing harm continue to do harm; let the one who is vile continue to be vile; let the one who is righteous continue to live righteously; let the one who is holy continue to be holy.”

12“Look, I am coming soon, bringing my reward with me to repay all people according to their deeds. 13I am the Alpha and the Omega, the First and the Last, the Beginning and the End.”

14Blessed are those who wash their robes. They will be permitted to enter through the gates of the city and eat the fruit from the tree of life. 15Outside the city are the dogs—the sorcerers, the sexually immoral, the murderers, the idol worshipers, and all who love to live a lie.

16“I, Jesus, have sent my angel to give you this message for the churches. I am both the source of David and the heir to his throne.^e I am the bright morning star.”

17The Spirit and the bride say, “Come.” Let anyone who hears this say, “Come.” Let anyone who is thirsty come. Let anyone who desires drink freely from the water of life. 18And I solemnly declare to everyone who hears the words of prophecy written in this book: If anyone adds anything to what is written here, God will add to that person the plagues described in this book. 19And if anyone removes any of the words from this book of prophecy, God will remove that person’s share in the tree of life and in the holy city that are described in this book.

20He who is the faithful witness to all these things says, “Yes, I am coming soon!”

Amen! Come, Lord Jesus!

21May the grace of the Lord Jesus be with God’s holy people.^f

Revelation 22:7-21 NLT

End of story.

~Blessings,

Mike

P.S. Please also read the following:

Nicole (22 Nov 2013)
"Dream from God about the Mark of the Beast!"

Guys I had a disturbing dream. I saw a free speech zone in the USA that a gentleman had sort of an outdoors broadcast for his radio show. He was doing some kind of internet radio or something like that. Anyways the Lord told me in the dream to go to this man. The Lord specifically told me for him to broadcast two major things. So in the dream I was afraid that no one would listen but I was obedient and I walked up to him and said JESUS DELIVERED ME IN ONE DAY FROM TWO SEVERE EATING DISORDERS, ANOREXIA AND BULEMIA AND HE DELIVERED ME FROM ALCHOL.

THE LORD WANTS ME TO URGENTLY TELL YOU THAT A TYPE OF ADVANCED MICROCHIP WILL BE IMPLEMENTED THROUGH THE HEALTHCARE SYSTEM AND IS WAY MORE ADVANCED THAN WHAT THEY ARE TELLING YOU. So then he said to me, wow I need to broadcast that.

All of a sudden I saw a lot of Christians come into the booth and they seemed excited that it was the end of time for what I was saying. And I knew that others were saying the same thing. But then the other Christians started talking "fluff" and they drowned out the message of DELIVERANCE OF ADDICTIONS AND SATANIC OPPRESSION AND THE MARK OF THE BEAST so much so that the radio announcer got caught up in talking to those people and my message did not even get on the air.

And so the Lord wants Christians right now to stop talking about FLUFF and get to the people and scream at them that the mark of the beast is coming, because you and I know that a lot of people are going to be left behind.

MMEA (Multi Electrode Array) Darpa Advanced Microchip
http://www.youtube.com/watch?v=mGJrFPFBPag

Remember in 2010-2011 my son had a dream that the TSA was trapping you in a security area and you could not leave UNLESS YOU HAD THE MARK! Guys, the set up for this is happening now! http://www.youtube.com/watch?v=g1G3nY7XopI

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

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.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health

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

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm072141.htm

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, electronic comments may be submitted to Regulations.gov¹. 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

A. BIOCOMPATIBILITY
B. INFORMATION SECURITY PROCEDURES (DESIGN AND VALIDATION)
C. SOFTWARE VALIDATION
D. MIGRATION TESTING OF IMPLANTED TRANSPONDER
E. PERFORMANCE TESTING OF IMPLANTED TRANSPONDER
F. PERFORMANCE TESTING OF INSERTER
G. PERFORMANCE TESTING AND HAZARD ANALYSIS OF ELECTRONIC SCANNER
H. ELECTROMAGNETIC COMPATIBILITY
I. ELECTRICAL SAFETY PERFORMANCE TESTING
J. STERILITY
K. MAGNETIC RESONANCE IMAGING COMPATIBILITY
L. 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. 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 Issues²” 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 820.30³.

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.

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