Medical Gas Professional Healthcare Organization

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FDA Request for Comments

  • Wednesday, March 23, 2016 9:14 AM
    Message # 3901747

    Everyone in the medical service industry should be aware that the FDA has put out a Notification Request for Comments Docket #FDA-2016-N-0436. This can be accessed from the FDA website at https://www.regulations.gov/#!documentDetail;D=FDA-2016-N-0436-0001  The Food and Drug Administration (FDA or we) is announcing the establishment of a docket to receive information and comments on the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices (hereafter termed “third-party entity or entities”), including radiation-emitting devices subject to the electronic product radiation control (EPRC) provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA is taking this action, in part, because various stakeholders have expressed concerns about the quality, safety, and continued effectiveness of medical devices that have been subject to one or more of these activities that are performed by both original equipment manufacturers (OEM) and third parties, including health care establishments. We are seeking comments from the widest range of interested persons, including those who are engaged in one or more of the activities noted previously or who utilize refurbished, reconditioned, rebuilt, remarketed, remanufactured, or third-party serviced and repaired medical devices.

     

    I spoke with the FDA yesterday and was told this applies across the board for servicing all medical devices, not just those listed.  I strongly recommend whoever can submit a comment should.  This very well could effect may of our businesses. 

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