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FDA addresses devices service, maintenance, refurbishment and alteration by OEM and 3rd parties

Discussion in 'US Medical Device Regulations' started by Ronen E, Mar 4, 2016.

  1. Ronen E

    Ronen E Well-Known Member

    Jul 31, 2015
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    "Today the FDA opened a docket for public comment titled, “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by ThirdParty Entities and Original Equipment Manufacturers; Request for Comments.” This docket is open for comments concerning the service, maintenance, refurbishment, and alteration of medical devices, by thirdparty entities, as well as challenges thirdparty entities face in maintaining or restoring devices to their original or current specifications. These devices include endoscopes, and radiationemitting devices subject to the electronic product radiation control (EPRC) provisions of the FD&C Act. We seek comments from the medical device industry and the healthcare community, and from other interested persons, including those that use these types of devices. This docket is not intended to address the reprocessing of singleuse or reusable medical devices. The comment period will be open for 60 days.

    The 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 when performed by both original equipment manufacturers and third parties, including health care establishments.

    The FDA also intends to hold a public meeting later in 2016 to further engage this segment of the device industry and healthcare community. Your comments to this public docket will help inform the content of the public meeting."