News: FDA invites comments on remanufacture of medical devices
Food and Drug Administration (FDA) announces the establishment of a docket to receive comments and information on the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medic
Tuesday, 5th April 2016
The Food and Drug Administration (FDA) announced this week 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 FDC Act).
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 performed by both original equipment manufacturers (OEMs) and third parties, including health care establishments.
The FDA is 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 utilise refurbish, recondition, rebuild, remarket, remanufacture, or third-party service and repair medical devices.
Either electronic or written comments must be submitted by May 3, 2016.
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