Implanted Neuromuscular Stimulator Notice Comments Dates Released

This post was written by Judith L. Harris and Amy S. Mushahwar.

As previously reported, the Federal Communications Commission ("FCC") proposes to allot spectrum and adopt service and technical rules for new implanted medical devices that would expand the use of functional electric stimulation to restore sensation, mobility and function to paralyzed limbs and organs. As an update to this report, yesterday the FCC published the Notice of Proposed Rulemaking ("Notice") regarding implanted neuromuscular simulators in the Federal Register and released the comments dates. Comments are due August 11, 2009 and replies are due on September 10, 2009.

This additional allotment for electronic stimulation technologies could be used to develop devices for the medical treatment for millions of people living with brain and spinal cord injuries and neuromuscular disorders, such as multiple sclerosis, polio, cerebral palsy and Lou Gehrig’s Disease. These implanted neuromuscular micro stimulators would function as wireless broadband medical micro-power networks (“MMNs”) within a patient. By eliminating the wires now used to interconnect multiple implanted neuromuscular micro stimulators and the external power source for the implants, MMNs would greatly reduce the risk of infection and increase patient mobility and system reliability.

The Notice seeks comment on the feasibility of allowing up to 20 MHz of spectrum in the 413–457 MHz band to be used under the Medical Device Radiocommunication Service (“MedRadio Service”) in Part 95 of the Commission’s rules, and seeks comment on the allocation of four specific segments for this purpose: 413–419 MHz, 426 432 MHz, 438–444 MHz, and 451–457 MHz. The Notice also seeks comment on the prospective service and technical rules that would govern MMN operations, such as transmitter power, emission bandwidth, duty cycle, contention protocols, and other operating specifications that generally comport with the framework of the existing MedRadio Service. The Notice proposes to limit MMN operations to use only by persons for diagnostic and therapeutic purposes, and only to the extent provided under the direction of authorized health care professionals.

FCC Allocates More Spectrum to Wireless Medical Devices and Proposes Even More Spectrum for Implanted Neuromuscular Stimulators

This post was written by Judith L. Harris and Amy S. Mushahwar.

The Federal Communications Commission (“FCC”) recently released an Order allocating 2 MHz of new spectrum for advanced wireless implanted devices, which may enable the certification of new devices by the FCC’s Office of Engineering and Technology.

The FCC also seeks comment on a proposal to allocate up to 20 MHz of spectrum for implanted neuromuscular micro stimulators. This additional allotment for electronic stimulation technologies could be used to develop devices for the medical treatment for millions of people living with brain and spinal cord injuries and neuromuscular disorders.

Parties interested in registering new devices under the FCC’s Order or in commenting on the additional spectrum allotment for electronic stimulation technologies are encouraged to contact Judith L. Harris or Amy S. Mushahwar.

For additional information, please see Reed Smith's full alert.