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U.S. Department of Health and Human Services

Medical Devices

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Federal Communications Commission (FCC) Seeking Information About Present and Future Uses of Radio Transmitters in Medical Devices

The FDA encourages all medical device manufacturers, designers, healthcare facilities and other users that utilize radio communications to respond to the Federal Communications Commission (FCC) Notice of Inquiry (NOI) released on July 18, 2006. [ http://hraunfoss.fcc.gov/edocs_public/attachmatch/FCC-06-103A1.pdf ] This NOI presents a unique opportunity to provide information to the FCC to help formulate future telecommunications plans and actions. The NOI includes questions about the present and future needs for medical device radio communications (which includes “wireless” technology). Information received by FCC will be coordinated with FDA to help address the issues surrounding wireless technology in and around medical devices and systems. The NOI comment period extends to October 31, 2006. Information about the NOI and filing comments can be found on the FCC web site: http://www.fcc.gov at http://wireless.fcc.gov/csinfo/comments.html. The FCC News release on this topic can be found at http://hraunfoss.fcc.gov/edocs_public/attachmatch/DOC-266397A1.pdf.

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