Tuesday, August 22, 2006
Attention Medical Device Engineers: The FCC Wants to Hear from You
Filed under: Regulation
As if your average regulatory science specialist didn't have enough to deal with, the FCC has announced a notice of inquiry (NOI) as to the use of radio transmission in medical devices...
In this proceeding, the Commission intends to modify its rules to accommodate the development and use of a variety of new medical devices that rely on radio communication for critical aspects of their functionality.1 These devices use wireless technologies for increasingly sophisticated and salutary health care applications. It is fair to say that quantum leaps in advanced medical technologies are revolutionizing treatment for a wide variety of medical conditions and, even more fundamentally, creating new health care models serving to improve quality of life for all Americans.The Commission presently has rules in place for wireless medical radio communication technologies that were based on initial devices and their applications. It now appears, however, that the pace and nature of development of newer, more capable, and more sophisticated devices may be inadequately accommodated by those rules. Some current developments and devices are familiar to us, and the nature of the rule changes necessary to better provide for them seem readily apparent. We are also expectant, however, that there will be following generations of devices with which we are not yet adequately familiar, and whose needs should be taken into consideration to the extent they can be anticipated.
They want your input now so you don't come back whining about what a pain FCC regulations are 5 years from now. Use this opportunity to submit some expert comments at the FCC's comment submission site, but you should probably read the full document (.pdf) first.
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