PALM BEACH, Fla. -- In a major decision that could pave the way for implanted chips in humans, Applied Digital Solutions Inc. here today announced that the U.S. Food and Drug Administration (FDA) will not regulate the company's new ID chip line as medical device.
The FDA made its decision in the form of written guidance to Applied Digital. The announcement clears the way for the company to begin sales, marketing and distribution of its VeriChip chip line in the United States, said Scott R. Silverman, president of the Palm Beach-based company.
In December, the company announced a tiny wireless ID chip that can be implanted in humans for medical, security and related applications. The ID chip, called VeriChip, is a radio-frequency (RF) device that measures 12- x 2.1-mm--or roughly the size of the point of a typical ballpoint pen, according to the company (see Dec. 19 story ).
At the time, the human ID chip from the company had been reportedly approved by several nations, except for the United States. Now, the company is free to market the chip in the U.S. market.
"Since we introduced VeriChip to the world in December, it has received global recognition as life-enhancing technology," Silverman said. "This favorable FDA guidance was a major goal of Applied's new management team."
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