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Class I: General Controls
Class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. These devices are subject only to general controls. General controls cover such issues as manufacturer registration with the FDA, good manufacturing techniques, proper branding and labelling, notification of the FDA before marketing the device, and general reporting procedures. (Most Class I devices are exempt from the good manufacturing practices and/or the FDA notification regulations.) These controls are deemed sufficient to provide reasonable assurance of the safety and effectiveness of the device; or the device is not life-supporting or life-sustaining and does not present a reasonable source of injury through normal usage. Devices in this category include tongue depressors, bedpans, elastic bandages, most hand-held dental instruments, examination gloves, and hand-held surgical instruments and other similar types of common equipment. Depending on the "stated/purported use" of a device, it may be necessary to obtain a Premarket Approval or 510K for the device, which is otherwise classifiable as a Class 1 device. Such devices are referred to as "reserved devices". The electrically powered arthroscope (which is really an endoscope powered electrically) is a case in point. While endoscopes are Class 1 devices, the electrically powered arthroscopes need a pre-market notification (510K) although the manual arthroscopes do not. Pre-market notified devices are marketed as "at least as safe and effective, that is, substantially equivalent, to a legally marketed device."
 Class II: General Controls with Special Controls
Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and additional existing methods are available to provide such assurances. Therefore, Class II devices are also subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and postmarket surveillance. 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.
 Class III: General Controls and Premarket Approval
A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices. Such a device needs premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I. Class III devices are described as those for which "insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls ... would provide such assurance and if, in addition, the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury."
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).
Tiny implant puts portable medical April 24 2006
The technology would allow physicians and medical personnel access to personal and medical records in cases where patients are unconscious or otherwise noncommunicative.
By Tyler Chin, AMNews staff. April 24, 2006. A small but increasing number of people are getting a portable health record in an intimate way -- by having a computer chip implanted in their arms.
When read by a scanner, the chip, the size of a grain of rice, would give an identification number physicians and hospitals would use to log on to a secure Web site containing that patient's identification and medical information. The chip and technology is produced by VeriChip, whose corporate parent owns another company --
Digital Angel --that has sold 6 million similar chips implanted in dogs and cats since 1991. Former Health and Human Services Secretary Tommy Thompson is a VeriChip board member and has pledged to get himself "chipped."
Originally posted by excalibur2009
pg. 1001 on the HR 3200 IH
It says that the registry will be implemented even if regulations have not been finalized.
Can anyone find reliable information about whether it will be mandatory for people to get micro-chipped?
(2) EFFECTIVE DATE.—The Secretary of
16 Health and Human Services shall establish and
17 begin implementation of the registry under section
18 519(g) of the Federal Food, Drug, and Cosmetic
19 Act, as added by paragraph (1), by not later than
20 the date that is 36 months after the date of the en21 by not later than 20 the date that is 36 months after the date of the en21 actment of this Act
actment of this Act, without regard to whether or
22 not final regulations to establish and operate the
23 registry have been promulgated by such date.
Originally posted by thetruth777
There's a pretty starling thing in the bill that 95% of Americans won't like.
The Obama Health care bill under Class II (Paragraph 1, Section B) specifically includes ‘‘(ii) a class II device that is implantable." Then on page 1004 it describes what the term "data" means in paragraph 1, section B:
14 ‘‘(B) In this paragraph, the term ‘data’ refers to in15
formation respecting a device described in paragraph (1),
16 including claims data, patient survey data, standardized
17 analytic files that allow for the pooling and analysis of
18 data from disparate data environments, electronic health
19 records, and any other data deemed appropriate by the
What exactly is a class II device that is implantable? Lets see...
Approved by the FDA, a class II implantable device is a "implantable radiofrequency
transponder system for patient identification and health information." The purpose of a class II device is to collect data in medical patients such as "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."
This sort of device would be implanted in the majority of people who opt to become covered by the public health care option. With the reform of the private insurance companies, who charge outrageous rates, many people will switch their coverage to a more affordable insurance plan. This means the number of people who choose the public option will increase. This also means the number of people chipped will be plentiful as well. The adults who choose to have a chip implanted are the lucky (yes, lucky) ones in this case. Children who are "born in the United States who at the time of birth is not otherwise covered under acceptable coverage" will be qualified and placed into the CHIP or Children's Health Insurance Program (what a convenient name). With a name like CHIP it would seem consistent to have the chip implanted into a child. Children conceived by parents who are already covered under the public option will more than likely be implanted with a chip by the consent of the parent. Eventually everyone will be implanted with a chip. And with the price and coverage of the public option being so competitive with the private companies, the private company may not survive.
So will everyone be covered by the public option eventually??????
And does that mean everyone will be chipped?????
SANITA’ DI OBAMA’: DAL 2013 OBBLIGATORIO MICROCHIP SOTTOCUTANEO
a proposito del disegno di legge sulla salute presentato da Obama e che a partire dal 2013 renderà obbligatorio per tutti i cittadini statunitensi l’impianto di un microchip Rfid che contenga tutte le informazioni relative a ogni americano.
Originally posted by Atlantican
Thanks for this. You have HIT THE NAIL ON THE HEAD and found what exactly 100% of us have suspected would come down the pipe at some point. Whether by way of economic or medical means.
*THIS IS THE SMOKING GUN FOLKS*
Suddenly, "the crazies" don't seem that crazy anymore.
Originally posted by IMSAM
hope this helps the conversation
Originally posted by IMSAM
hope this helps the conversation