| XIV. | Human Microchip Implants: Government |
| Posted: December 29, 2003 |
| A. | Human Microchip Implants: Federal Communications Commission (FCC) Approval |
| 1. | Digital Angel Has FCC Approval: WorldNetDaily: February 4, 2002 |
| WorldNetDaily reported that Digital Angel has FCC approval. |
| ADS acquired the company [Destron Fearing] in order to leverage its management experience and relevant technologies...Under the guise of Destron Fearing, Digital Angel has won FCC licensing approval of the frequencies needed for widespread tracking of humans.267 |
| 2. | Applied Digital Solutions Says Has Permission from FCC: Los Angeles Times: December 19, 2001 |
| The Los Angeles Times reported that Applied Digital Solutions says that it has permission from the FCC. |
| A Florida company is poised to become the first to sell microchips designed to be implanted into human beings, an achievement that opens the door to new systems of medical monitoring and ID screening... |
| The company [Applied Digital Solutions] said it already has secured permission from the Federal Communications Commission--necessary because the chips use radio frequencies.268 |
| 3. | Applied Digital Solutions Claims Has Approval from FCC: December 19, 2001 Los Angeles Times summarized in December 20, 2001 NLECTC Law Enforcement & Corrections Technology News Summary |
| The National Law Enforcement and Corrections Technology Center (NLECTC) in the December 20, 2001 Law Enforcement & Corrections Technology News Summary notes that Applied Digital Solutions claims, in regard to its implanted microchips, that it has gained approval from the FCC. |
| Applied Digital Solutions of Palm Beach is planning to capitalize on microchips that can be implanted within the human bodyÉApplied Digital expects the FDA to approve the chips by the middle of next year; the company claims to have gained approval from the FCC, since the chips use radio frequencies.269 |
| B. | Human Microchip Implants: Food and Drug Administration (FDA) |
| 1. | Applied Digital Solutions Expects to Receive FDA Approval: The Los Angeles Times: December 19, 2001 |
| The Los Angeles Times reported that Applied Digital Solutions expects to receive FDA approval. |
| A Florida company is poised to become the first to sell microchips designed to be implanted into human beings, an achievement that opens the door to new systems of medical monitoring and ID screening... |
| The chips would need approval from the Food and Drug Administration, which Applied Digital said it expects to receive by midyear.270 |
| 2. | FDA Will Not Regulate Implantable Chip in People if Contains No Medical Data: Associated Press on washingtonpost.com: April 4, 2002 |
| The FDA will not regulate implantable chips in people if the chips do not contain medical data. |
| A company plans to begin selling a computer ID chip that can be embedded beneath people's skin, now that the Food and Drug Administration has said it will not regulate the implant as long as it contains no medical data... |
| Applied Digital had held off sales pending discussions with the FDA of whether an implanted chip would be considered a medical device. If the chip solely provides identification, it needs no FDA clearance, the agency confirmed Thursday-advice officials have long given others developing ID for tracking children, prisoners or workers with top-security clearances. |
| But, "if they put medical records in, we would be concerned about the use," said the FDA's medical device chief, Dr. David Feigal, who made clear that the agency could step in at that point... |
| For now, the VeriChip will bear only an identification number, said David Hughes of Technology Sourcing International, a consulting firm helping Applied Digital in its discussions with the FDA. But that ID code could be cross-referenced with a database to detail any kind of information. |
| The company said production would begin immediately.271 |
| 3. | "VeriChip Receives Favorable FDA Guidance": Business Wire: April 4, 2002 |
| Business Wire reported that "VeriChip Receives Favorable FDA Guidance." |
| Applied Digital Solutions, Inc. (Nasdaq: ADSX), an advanced technology development company, announced today that it has received written guidance that the U.S. Food and Drug Administration (FDA) does not consider VeriChipTM to be a regulated device. |
| This clears the way for the company to begin sales, marketing and distribution of VeriChipTM in the United States. |
| Commenting on the FDA notification, Scott R. Silverman, President of Applied Digital Solutions said: "...This favorable FDA guidance was a major goal of Applied's new management team. It has been accomplished. We can now begin to sell, market and distribute VeriChip in the United States."272 |
| 4. | FDA: VeriChip: "Not Considered a Medical Device and Therefore Is Not Subject to FDA Regulation": Newsfactor: April 5, 2002 |
| A NewsFactor Network article, entitled, "Implantable Spy Chip Gets Green Light from U.S.," reported that an implantable microchip received the "go-ahead from the U.S. Food and Drug Administration." |
| A Florida company Thursday said that it will begin marketing and selling a microchip that can be implanted under the skin, after receiving the go-ahead from the U.S. Food and Drug Administration (FDA). |
| The FDA advised the company, Applied Digital Solutions (Nasdaq: ADSX), that its biochip, called "VeriChip," is not considered a medical device and therefore is not subject to FDA regulation. |
| FDA officials said that as long as the biochip is used for identification purposes only, it will not have to meet strict FDA guidelines. The ruling saves the product from having to undergo the agency's rigorous and lengthy safety testing procedures. |
| "The FDA said that VeriChip has no medical function, and Applied Digital Solutions is now free to sell, market and insert the chips in individuals," company spokesperson Matthew Cossolotto told NewsFactor. |
| 'Distinction Without a Difference' |
| Although the company has advertised the VeriChip in the past as a potential method of storing a person's complete medical history, at this stage the device will contain only a number to be used for identification. |
| However, that ID code can be transmitted via Internet or phone to a secure data storage site, where it can be cross-referenced, allowing authorized personnel to obtain detailed medical information. |
| "In some ways, it's kind of a distinction without a difference," Cossolotto said. "We could have, and we might in the future, put more information on the chip. But right now we're very happy to put just the ID verification code and start getting it into the marketplace." |
| The company said it has targeted VeriChip and its "life-enhancing" technology toward patients who may arrive at hospitals unconscious or unable to speak, as well as at workers who need top-security clearance. |
| The biochip also could prove valuable for tracking children, Alzheimer's patients and convicted felons on parole. |
| Similar technology has been used in the last few years to keep track of pets.273 |
| 5. | Applied Digital Solutions: FDA: Testing Not Required for Implantable Chip: The New York Times on the Web: April 5, 2002 |
| The New York Times on the Web, in a "Technology Briefing" section, reported that Applied Digital Solutions said that the FDA does not require the company's implantable chip to "undergo testing by the Food and Drug Administration." |
| IMPLANTABLE CHIP HEADED FOR MARKET A skin-embedded computer chip is not required to undergo testing by the Food and Drug Administration and will thus be available soon, the company that designed the product said. The company, Applied Digital SolutionsÉ, has publicized the device, called Verichip, as a substitute for medical tags, saying that wireless readers could be used with it to get information like the pacemaker model or drug allergies of a person brought to a hospital. In reality, however, the chips would only contain identification codes that would refer to a database of medical information. Applied Digital Solutions said because the chip would not contain medical information, the product was able to avoid F.D.A. review. The company has said it will begin distributing equipment to read the chips to hospitals in Palm Beach and Broward Counties in Florida...Scott Silverman, the chief executive, said it was shifting its focus from the information technology business to emerging technologies like Verichip.274 |
| 6. | Applied Digital Solutions Requested a Modification of Nasdaq Decision Based in Part on FDA Regulatory Review Process: Business Wire: October 17, 2002 |
| Applied Digital Solutions requested "an additional 60 days to comply with $1.00 minimum bid price requirement...based in part, on the prolonged and unexpected regulatory review process by the FDA concerning VeriChip(TM)." |
| Applied Digital Solutions, Inc. (Nasdaq: ADSX), an advanced technology development company, announced today that it has requested that the NASDAQ Listing Qualifications Panel modify its prior decision NQ4063N-02. |
| ...The Company's request is based, in part, on the Food and Drug Administration's (FDA) prolonged and unexpected regulatory review process concerning VeriChip, the Company's subdermal personal verification microchip. |
| Specifically, at the suggestion of FDA officials in June, the Company voluntarily submitted two separate written requests to the Center for Devices and Radiological Health (CDRH) under Section 513(g) of the Federal Food, Drug, and Cosmetic Act (FDC Act). The first "513(g)" request, which was received by the FDA on July 1, 2002, concerned VeriChip's use in security, financial, and personal identification/safety applications. |
| The second "513(g)" request, received by the FDA on July 9, 2002, covered the use of the VeriChip in health information applications. In both applications, the Company requested an FDA determination that VeriChip is not a regulated "device" as defined by the FDC Act for the intended uses described in the 513(g) requests. |
| The FDC Act requires the FDA to respond to 513(g) requests with a decision within 60 days of receipt. The 60-day response period for the first 513(g) request expired on September 1, 2002, while the response period for the second request expired on September 8, 2002. |
| Commenting on the Company's request to NASDAQ and the FDA's review process, Scott R. Silverman, President of Applied Digital Solutions, said: "Without question, the Company respects the FDA and the important role it plays in protecting the health and safety of the public. Throughout this prolonged process, the Company has cooperated fully, even voluntarily suspending further commercial "chipping" procedures in the United States. Based on our legal counsel's extensive review of relevant statutes, the Company continues to believe firmly that VeriChip is not a medical device as defined by law and could therefore lawfully be marketed right now. However, out of respect for the Agency and our desire to cooperate, we have not begun to market the product here in the United States. In view of the expired 60-day deadlines for responding to our 513(g) applications, we have respectfully requested that the FDA provide us with the necessary clarification immediately. We believe these unusual and extenuating facts justify the 60-day extension. In the worst case, the Company would move to the NASDAQ Small Cap Market. In this event, the Company remains confident that within the next 180 days it will be able to satisfy the minimum bid requirement and regain national market listing."275 |
| 7. | "FDA Ruling - Subdermal VeriChip is Not a Regulated Medical Device 'For Security, Financial, and Personal Identification/Safety Applications' ": Business Wire: October 22, 2002 |
| Business Wire reported that Applied Digital Solutions said that the FDA determined that a subdermal chip "is not a regulated medical device 'for security, financial, and personal identification/safety applications.' " |
| Applied Digital Solutions, Inc....today announced that the Food and Drug Administration (FDA) has determined that VeriChip is not a regulated medical device "for security, financial, and personal identification/safety applications." |
| The Agency specified in its ruling that VeriChip is a regulated medical device for health information applications "when marketed to provide information to assist in the diagnosis or treatment of injury or illness." |
| The ruling was communicated to the Company by letter from the FDA. The FDA's decision - responding to the Company's pending "513(g)" applications - comes five months after the Company voluntarily suspended marketing of VeriChip in the United States pending review of VeriChip by the FDA. As a result of the FDA's ruling, the Company will immediately resume sales, marketing and distribution efforts of VeriChip in the United States for security, financial, and personal identification/safety applications. |
| Commenting on the FDA's ruling, Scott R. Silverman, President of Applied Digital Solutions, said: "We are very pleased with the FDA's decision. Although the process took longer than expected, the Company is thrilled to be able to bring this exciting technology to market in the United States. In the next several days, we will outline our domestic sales, marketing and distribution plans and provide further updates on our international sales and expansion efforts."276 |
| 8. | Warning Letter to Applied Digital Solutions: Food and Drug Administration (FDA): November 8, 2002 |
| The FDA sent a Warning Letter dated November 8, 2002, addressed to Mr. Richard J. Sullivan, Chairman/Chief Executive Officer, Applied Digital Solutions. The URL for the FDA Warning Letter was http://www.fda.gov/foi/warning_letters/g3668d.htm. Following is an excerpt from part of the second paragraph of the November 8, 2002 FDA letter.277 |
| As the Food and Drug Administration (FDA) has repeatedly advised ADS and its counsel, most recently by letter from the Office of the Chief Counsel dated October 21, 2002, the VeriChip is a medical device if it is marketed with claims of medical utility (e.g., to provide access to medical history or other information to assist medical personnel in diagnosing or treating an injury, illness, or condition)ÉIndeed, the "marketing plan" described in Mr. Silverman's letter appears to hinge precisely on the very claims of medical utility that, as we have repeatedly advised ADS, make the VeriChip a medical device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or Act), 21 U.S.C. 321(h). ADS's conduct flagrantly disregards FDA's prior comprehensive advice. |
| 9. | Applied Digital Solutions Announced A Few Weeks Before That The FDA Determines VeriChip Not A Regulated Medical Device "for Security, Financial, and Personal Identification/Safety Applications": Business Wire: November 12, 2002 |
| Applied Digital Solutions announced that the FDA determined that VeriChip is not a regulated medical device for "security, financial, and personal identification/safety applications." A Business Wire release, entitled, "Applied Digital Solutions to Participate in Seminar on Human Implantable Microchips at the National Academies—Nov. 15, 2002, in Washington," stated: |
| The seminar is taking place just a few weeks after Applied Digital Solutions announced that the FDA had determined that VeriChip is not a regulated medical device for security, financial, and personal identification/safety applications. The Agency specified in its ruling that VeriChip is a regulated medical device for health information applications.278 |