The Federal Communications Commission is seeking comments from interested parties in the medical device and health care communities with regard to a request filed by DexCom, Inc. for a waiver of the FCC’s frequency monitoring requirements. These requirements apply to DexCom’s blood glucose monitoring system, a system that is regulated by the FCC’s Medical Implant Communications Service (MICS) rules. The resolution of this proceeding will greatly impact the following entities:

• Medical device manufacturers subject to the MICS rules, and particularly the “listen before transmit requirement” contained in those rules.
• Hospitals and health care providers concerned about the impact of the FCC’s frequency monitoring rules on patients requiring medical implants.

In its Waiver Request, DexCom states that its system is comprised of two devices: a short-term blood glucose monitoring sensor (STS) device and a long-term blood glucose monitoring sensor (LTS) device. DexCom indicates that it has requested Food and Drug Administration pre-market approval for its STS device and that it plans by early next year to request similar approval for its LTS device. DexCom contends that, given the serious health and financial consequences of diabetics failing to manage their glucose levels adequately, the medical community and diabetics are anxious to have access to its system as soon as possible.

However, DexCom states, its STS and LTS devices are incapable of satisfying the “listen before transmit” requirement that the MICS rules impose on all transmissions that do not constitute a medical implant event. DexCom therefore requests a waiver to permit its system to transmit periodically.

The FCC is seeking comments from interested parties on the DexCom waiver. Initial comments must be filed by July 15, 2005, and Reply comments must be filed on or before August 1, 2005.

Entities interested in participating in this proceeding, or learning more about the FCC’s regulation of medical devices, are invited to contact Jeffrey Rummel and Alan Fishel, of the firm’s Telecommunications practice group.