ID, Patient & Health Info Chip, FDA Classifies Implantable Chip www.gpoaccess.gov/fr/index.html. www.fda.gov/cdrh.

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Class II Special Controls Guidance Document: Implantable Radiofrequency

Transponder System for Patient Identification and Health Information, "

 

 

FDA Classifies Implantable Chip

Mobile Health Data

December 10, 2004

 

The Food and Drug Administration has published a final rule classifying the

VeriChip implantable radio frequency identification system as a Class II medical

device with special controls. The special controls that will apply to the device

-- which the FDA recently approved for marketing -- are explained in a guidance

document the agency also has published. The FDA on Dec. 10 published in the

Federal Register the final rule and a notice about the guidance document,

available at www.gpoaccess.gov/fr/index.html.

 

Text of the guidance, document number 1541 and titled, " Class II Special

Controls Guidance Document: Implantable Radiofrequency Transponder System for

Patient Identification and Health Information, " is available at

www.fda.gov/cdrh.

 

The grain-sized VeriChip from Delray Beach, Fla.-based Applied Digital is

designed to enable physicians to have electronic access via the Internet to

specific patient information, such as allergies or medical history. The chip,

inserted under the skin on the right arm, contains a 16-digit identification

number that is captured by passing a proprietary scanner over the insertion

site. The identification number links to a database containing the patient's

medical information. The technology already is used in several non-medical

procedures, such as identifying pets and livestock, and granting physical access

to secure areas, according to the vendor. For more information, visit

www.adsx.com.

 

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