OET Approves Waiver for Systems Designed to Help Amputees
The FCC Office of Engineering and Technology approved a waiver allowing The Alfred Mann Foundation (AMF) for Scientific Research to market the first generation of new medical devices for amputees. The system uses medically implanted sensors to allow amputees to…
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have “more intuitive control of their prosthetic devices,” OET said. But the first generation of the system uses the 94.6-157.4 kHz band “during start-up modes lasting less than one second in order to configure the implanted sensors,” which under FCC rules wasn't permissible without a waiver, OET said in a letter to AMF. “You argue that requiring a redesign of these first-generation systems would delay the FDA approval process for both first- and future- generation IMES systems, because FDA approval of new, next-generation … devices relies heavily upon approval of the first-generation devices,” OET said. “You also confirm that future-generation … systems will be redesigned to operate on a different, non-restricted frequency to comply with the rules.” OET said it found “good cause” to approve the waiver. “This is a compelling situation, in which technology will improve the quality of life for amputees based on speedy approval by the FDA for this first-generation design,” OET said.