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  • FDA, ONC Issue Long-Awaited Health IT Framework

    The US Food and Drug Administration (FDA) has released for consultation a new proposed framework on how to regulate health information technology (IT), including mobile medical device applications ("apps") according to risk. Background Mobile medical applications can best be understood as programs run on a mobile device such as a smartphone or tablet that allow a user to access a medical technology wherever and whenever they wish. For example, a smartphone application t...
  • FCC Regulation Aims to Promote Medical Device Innovation

    • 30 April 2013
    A new regulation published by the Federal Communications Commission (FCC) would serve to streamline the Experimental Radio Service (ERS), a block of radio spectrum meant to promote innovation, including its medical testing license, now used in some medical device products. Background The ERS is basically a set of rules that "prescribe the manner in which the radio spectrum may be made available to manufacturers, inventors, entrepreneurs and students to experiment with n...
  • FCC Conducting Review of Hearing Aid-Focused Regulations

    • 15 January 2013
    The US Federal Communications Commission's (FCC) Wireless Telecommunications Bureau has announced the extension of a comment period on a review of its regulations on a type of medical device now used by millions of Americans: hearing aids. The extension is the second in the last two months, this time owing to the FCC's understanding that the deadline fell on the same day as a critical filing deadline for all handset manufacturers (Form 655). Currently, FCC regulatio...
  • FCC Releases Regulations Governing Medical Body Area Network Devices

    • 11 September 2012
    The Federal Communications Commission (FCC) has released a final rule laying out its expectations for the development and approval of new Medical Body Area Networks (MBANs)-short-range, low-energy wireless networks capable of connecting numerous medical devices together. The rule follows a May 2012 announcement by FCC approving the MBAN system concept. At the time, FCC said it was dedicating the 2360-2400 MHz spectrum band to the device class on a secondary-that is, sh...
  • FCC Approves First-in-World Plan to Dedicate Spectrum to Networked Medical Devices

    • 24 May 2012
    In an expected move, the Federal Communications Commission (FCC) approved a plan to dedicate a new band of shared spectrum to an emerging class of medical devices known as Medical Body Area Networks (MBANS). MBANS are effectively networks composed of multiple wireless medical devices capable of communicating with one another. FCC had been publicly touting its intent to dedicate the 2360-2400 MHz spectrum band to the emerging MBAN device class since at least April 2012....
  • FCC Unveils Plan to Release New Spectrum for Wireless Medical Devices

    The Federal Communication Commission's (FCC) Chairman, Julius Genachowski, unveiled a plan to release new wireless spectrum to support the development of Medical Body Area Networks (MBANs), saying the new spectrum will help advance patient safety and device innovation. Under the plan, MBANs, or networks composed of multiple wireless medical devices capable of communicating with one another, will be bolstered by a "multi-track mobile action plan to free up more spectrum f...
  • FCC Pushing to Release New Spectrum for Medical Devices

    The US Federal Communications Commission's (FCC) Chairman, Julius Genachowsky, is planning to deliver remarks at an event on 17 May where he will advocate releasing new wireless spectrum to support Medical Body Area Networks (MBANs)-networks composed of multiple medical devices capable of communicating with one another. As Scientific American reported in 2009 , "an MBAN would help hospitals and healthcare clinics better keep tabs on important health-related informatio...
  • As Mobile Applications Cross Over Into FDA Regulatory Territory, New Frictions Emerge

    Developers of mobile medical applications are increasingly encroaching onto territory traditionally overseen and regulated by the US Food and Drug Administration (FDA), and the overlap is causing an uncomfortable friction between developers used to oversight-free development and FDA's legislative mission to protect consumers, reports  Politico . The emerging clash follows FDA's promulgation of draft guidance in July 2011, when it proposed some basic regulatory prin...
  • Congressmen Pressure FDA, FCC Over Wireless Health Regulation

    A group of six Republican Representatives sent the Commissioners of the US Food and Drug Administration (FDA) and the Federal Communications Commission (FCC) a letter cautioning the agencies against issuing "slow and inconsistent regulations," reports Mobi Health News . "These new technologies increasingly cross two regulatory structures," the Congressmen state in the letter. "It is critical that the two agencies act in concert to provide regulatory predictability, cons...
  • FCC Unveils New Spectrum for Implantable Neuromuscular Microstimulation Devices

    • 27 January 2012
    The US Federal Communications Commission (FCC) released new regulations on 27 January that opens up the existing Medical Device Radiocommunication (MedRadio) Service spectrum to allow medical implant devices employing neuromuscular microstimulation (MMN) techniques to use the spectrum. The Regulation, Additional Spectrum for the Medical Device Radiocommunication Service , is "part of a larger effort to recognize and facilitate the significant advances in wireless medi...
  • USP Releases Draft Standards for Probiotics and Microbial Food Cultures

    • 04 January 2012
    The US Pharmacopoeia (USP) on Tuesday released new draft standards to "help ensure the quality of probiotic food ingredients". The standards, released 2 January, are set to be incorporated in to the Food Chemicals Codex (FCC). The new standards- Microbial Food Cultures Including Probiotics- are contained within a new FCC Appendix and detail the essential quality specifications, intended uses in food, safety considerations, regulatory status, and purity of probiotics. ...