The Food and Drug Administration has ruled that an implantable microchip used for ID purposes is not a regulated device, paving the way for the chip's immediate sale in the United States, the manufacturer announced today.
For the past several weeks, Applied Digital Solutions has worked to get its VeriChip - biochip containing personal data that is similar to devices used to identify lost pets - classified as a non-regulated device. On Thursday, the company's wish was granted. "They inquired about the use of the product for non-medical, identification purposes," said FDA spokeswoman Sharon Snider. "If it's a non-medical use, the FDA doesn't regulate it."
Because the VeriChip won't be subject to the agency's rigorous safety tests, ADS will be able to launch the product over the next three months, said ADS president Scott Silverman, first in the company's headquarters of Palm Beach County, Florida, and then nationwide.
In the United States, the VeriChip has been marketed as a medical aid which would allow hospital workers to access patients' health records with a simple wave of the wand, or reader. While the FDA has not approved storing medical information on the chip, the device's ID could be cross-referenced with a computer database holding the patient's records.
In South America, the device has been bundled with a GPS-unit and sold to potential kidnapping victims. (The company is developing a separate implantable GPS product for kidnapping targets that should be completed in a year, Silverman said.) The company hasn't decided yet if it will sell or freely distribute the scanner needed to read the chip's 125-kHz signal to hospitals. The scanner is expected to cost between $1,000 and $3,000. ADS has been inundated with inquiries from teenagers and other technophiles who are impatient to get the device.
"We'll start the rollout with people who want it for medical concerns and Generation Y people who want to get chipped because they think it's cool," Silverman said. ADS plans to charge $200 for the chip (insertion would be free at certified clinics) and an annual $40 service fee for maintaining the users' database. The chip, which is slightly larger than a grain of rice, is inserted under local anesthesia during a quick outpatient procedure.
The VeriChip has fanned the fear among certain Christians who believe it may be the dreaded "Mark of the Beast" described in Biblical lore.
Among the first people to receive the VeriChip will be a Palm Beach County family called the Jacobs. The Jacobs family -- Leslie, Jeffrey, and their son Derek -- are interested in the chip for a variety of health, security and technolust reasons.
Jeffrey Jacobs, the father, suffers from multiple degenerative diseases and needs 10 medications a day to control pain and other problems. He believes the chip could save his life during an emergency if he were unable to communicate with health workers. His 12year-old son fantasizes about the merging of man and machine. And Jacobs' wife, Leslie, believes the chip could become a tamper-proof way to identify people in an increasingly insecure world.
"We are so thrilled to be part of this," Leslie Jacobs said, scoffing at privacy and religious concerns. "When they find out what this is really about, and that it can save people's lives, they'll change their minds."
By Julia Scheeres; Apr. 04, 2002