Please explain in the area below why an STA is necessary:
DexCom, Inc. (DexCom), in accordance with Section 5.61 of the Commissions rules, herein seeks extension of its existing Special Temporary Authority (STA) for a period of six (6) months to continue operation of up to 500 unique Medical Implant Communications Service (MICS) devices. As intentional radiators, albeit at extremely small power levels, MICS devices are not permitted to operate under the Commissions rules, even for the purposes of testing and demonstration, absent an equipment authorization. Accordingly, DexCom herein seeks extension of its experimental STA to permit it to complete its testing program involving devices at various home environments in 17 different metropolitan areas in the United States.
DexComs request for extension of its STA is supported by good cause. DexCom is using of its medical implant devices in order to gather feedback from medical patients who suffer from diabetes as well as the physicians who treat them. The information garnered from the operation of these devices has permitted DexCom to improve performance of the devices, enabling the company to continue to make modifications to its MICS chips before marketing the device. DexCom has been performing these experimental operations in anticipation of filing an application seeking authority under the Commissions equipment authorization rules in the near future.
DexCom believes that it will have completed its program of study within the next six months, utilizing the information from the program to finalize its diabetes monitors. This program of study is required by the FDA before it can consent to the manufacturing of the devices. To this end, DexCom maintains that this request is in the public interest.