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 is or has been used in or on a patient; and is—‘‘(i) a class III device; or ‘‘(ii) a class II device that is implantable, life-supporting, or life-sustaining. 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—‘‘(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

Originally posted by ThaLoccster
Simple research people.

As soon as I saw the terms class II and class III medical devices I just did a search, you know...to find out what a class II/III medical device is.

I'd also like to say, that as RFID implants exist today, none could be classified as a medical device. (Well, maybe a Class I device)

Medical Device

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.[2] (Most Class I devices are exempt from the good manufacturing practices and/or the FDA notification regulations.)[2] 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."

[edit] 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.[2] 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.

[edit] 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."[3]

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).

Do just a minor amount of research before you go all chicken little on everyone and claim the sky is falling.

[edit on 11/13/2009 by ThaLoccster]

Originally posted by thisguyrighthere
reply to post by ThaLoccster

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Nice. Implantable cerebral simulators. Reminds me of a certain Vonnegut story.

Anyway, saying the sky is falling based on this is definitely stupid. Just as stupid as saying no harm can come of this. Seems that by definition and example there is no reason a Class II or III medical device cannot be what so many here fear it could be.

Too broad, too vague, and if past experience with the government has taught me anything, too likely.

“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.”