Microchipping humans ~ FDA sources indicate Class II RF Chip in Waxman's healthcare bill, page 1

This is in response to Patmac's thread, Microchiping included in Healthcare Bill?.

This new information deserves a separate thread as many people had already "debunked" class II as being a pacemaker and numerous other devices that could fit into the wording of the bill.

The FDA refers to the RF ID chip specifically as a "Class II device" many times in Guidance for Industry and FDA Staff

[Complete article title: Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: 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."

"FDA's decision to exempt a Class II device from the requirement of premarket notification is based on..."

Edited to change title.


[edit on 14-11-2009 by notreallyalive]

Patmac I hope you don't mind co-authoring two threads with me
You had it right on as mentioned here in your previous thread, just needed that next step.

Originally posted by patmac here.

Buried deep within the over 1,000 pages of the massive US Health Care Bill (PDF) in a “non-discussed” section titled: Subtitle C-11 Sec. 2521— National Medical Device Registry, and which states its purpose as:

“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—‘‘(A) is or has been used in or on a patient; and ‘‘(B) is a class III device; or ‘‘(ii) a class II device that is implantable.”

In “real world speak”, according to this report, this new law, when fully implemented, provides the framework for making the United States the first Nation in the World to require each and every one of its citizens to have implanted in them a radio-frequency identification (RFID) microchip for the purpose of controlling who is, or isn’t, allowed medical care in their country.

Visit HERE for the full article and a link to the exact line in the document via Scribd.

What does this all mean??

It means that if Waxman's "America's Affordable Health Choices Act of 2009" healthcare bill passes, then American's can legally have radio frequency microchips implanted in them!

This is no longer conspiracy theory, it is FACT!



[edit on 14-11-2009 by notreallyalive]

Originally posted by notreallyalive

What does this all mean??

It means that if Waxman's "America's Affordable Health Choices Act of 2009" healthcare bill passes, then American's can legally have radio frequency microchips implanted in them!

This is no longer conspiracy theory, it is FACT!

Americans can legally have radio frequency microchips implanted in them now. If they want one.

All the Registry clause says is that a database for postmarket safety for Class II and III devices will be set up.

The other article linked to says that chips will be considered Class II.

en.wikipedia.org...
the classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860).

Devices in Class II are held to a higher level of assurance than Class I devices that they will perform as indicated and will not cause injury or harm to patient or user. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, surgical drapes, surgical needles and suture material,acupuncture needles.


Examples of Class III devices which require a premarket approval include replacement heart valves, silicone gel-filled breast implants, implanted cerebral stimulators, implantable pacemaker pulse generators and endosseous (intra-bone) implants (with the exception of root-form endosseous dental implants which were recently reclassified as Class II).

I don't think it says anywhere in there that chips are required or mandatory. If it does, please let me know and I'll panic.

reply to post by notreallyalive

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The bill that infowars linked to, specifically the National Medical Device Registry is amending parts of Section 519 of the Federal Food, Drug, and Cosmetic Act.

What it is doing, is actually introducing a stricter registry for these products.

The original can be found here.

Section 519 starts on page 222

Worth a read to see the full scope, I also noted that no where did it mention anything about a specific implant or chip, making your title misleading.


Regarding the FDA article, it seems to be discussing one particular device:

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.

This implant technology has been authorised for marketing since 2004, here's a supporting article discussing it:

wistechnology.com...

The second type of RFID medical device is the implantable radiofrequency transponder system for patient identification and health information. One example of this type of medical device is the VeriChip Health Information Microtransponder System, which includes a passive implanted transponder, inserter and scanner. The chip stores a unique electronic identification code that can be used to access patient identification and corresponding health information in a database. The chip itself does not store health information or a patient's name.

It seems to me there is a lot of straw clutching when trying to connect this with the health care bill, blind Obama hate reigns supreme over logic and fact checking it seems.

[edit on 14/11/09 by Chadwickus]

reply to post by Pauligirl

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This the exact thing I said in the other thread.

It could just be my common sense tingling, but the way I interpret this sentence....

“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—‘‘(A) is or has been used in or on a patient; and ‘‘(B) is a class III device; or ‘‘(ii) a class II device that is implantable.”

....is that they are creating a National Medical Device Registry, that would analyse and report the safety of devices, and report about outcomes of people who had such devices, including implantable ones. Rather they lived, died, improved, worsened, etc...

RFID chips have been legally implanted in people for various reasons for quite a few years. I remember a club in florida with RFID chip requirements long ago.

reply to post by notreallyalive

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Originally posted by notreallyalive


The bill clearly states, by definition, that they can implant microchip medical devices in us which allow access to medical information.

I'm not grasping at straws and making a big deal. I'm stating emperical factual data- take it as you like. I read the other thread; I know you've already made up your mind - maybe you should have an open mind as well and not assume I'm an Obama hater.


[edit on 14-11-2009 by notreallyalive]

Like I stated above, implants have been legally placed in people for quite awhile now. This bill isn't authorizing any implanting, the FDA did that already.

RFID

The Food and Drug Administration in the US has approved the use of RFID chips in humans.[81] Some business establishments give customers the option of using an RFID-based tab to pay for service, such as the Baja Beach nightclub in Barcelona.[82] This has provoked concerns into privacy of individuals as they can potentially be tracked wherever they go by an identifier unique to them. There are concerns this could lead to abuse by an authoritarian government or lead to removal of freedoms.[83]

That even mentions the florida club I mentioned above.

Feds approve human RFID implants

The US Food and Drug Administration (FDA) has approved a gimmick from Florida-based Applied Digital Solutions to chip people with RFID implants - previously confined to tracking animals - thereby making it easy to access their medical records, even when they cannot, or would rather not, cooperate.

Thats the [81] from the wikipedia article. Since 2004 RFID implants have been legal in humans.

reply to post by ThaLoccster

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Thanks. I'm not sure that FDA approval allows for overall legal use; thanks for the info nonetheless.

Originally posted by ThaLoccster
reply to post by Pauligirl

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This the exact thing I said in the other thread.

Great! Maybe if enough of us point out what it really says, people will quit screaming about getting chipped.

Naw. Never happen.

I had not heard about the nigh club thing. Wonder how many got it for the novelty?

reply to post by notreallyalive

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I wasn't having a dig at you about clutching at straws, it was more aimed at infowars.

As has been mentioned in this thread, these chips have been allowed to be used since as early as 2004, I linked to an article written by a member of the FDA stating these things.

The new bill is proposing more stringent tracking of all implanted devices.

I think this is where you're not getting it...I'll put it how I see it...If an implanted device, say a heart monitor malfunctions and kills the patient it was implanted in, the company who made or distributed the implant has 10 days to notify the FDA and provide details of all the same heart monitors implanted so the FDA can get in contact with these other patients, because if one is faulty then others could be too.
This is where the tracking part comes into play, Thye need to know where every single device is, so they need to keep highly detailed records of each implant and where it went. This is what the new bill is doing, bringing in more stringent record keeping.

reply to post by notreallyalive

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Honestly man, if the FDA approved it for a nightclub to use it to allow VIP access, I'd say it pretty much opened the door for anything.

reply to post by Chadwickus

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Thanks Chadwickus.

I agree with you and have can imagine many appropriate uses and normal reasons for the legislation. On the other hand, traffic cams are supposed to be used for traffic/red light purposes but I guarantee they're being used for much more.

In a generation people will be asking for chips anyway, "Why do we need to carry around these clumsy wallets when it can just be in our arm?"

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