HTM Discussion Group

FDA Rejects Push for Regulatory Action on Device Service

  • 1.  FDA Rejects Push for Regulatory Action on Device Service

    Posted 05-15-2018 15:47

    FDA Rejects Push for New Regulatory Action on Medical Device Service

    Posted May 15, 2018 

    The Food and Drug Administration (FDA) has concluded that there is insufficient evidence to justify imposing additional regulations on third-party servicers of medical devices. The announcement came this morning with the publication of a highly anticipated report on the quality, safety, and effectiveness of medical device servicing that was required as part of the FDA Reauthorization Act of 2017.

    The full article from AAMI on the new FDA report is available here



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    Patrick Bernat
    Director Standards, HTM
    AAMI
    Arlington VA
    (703) 525-4890
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