The FDA is seeking comments from the medical device industry and healthcare community that refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices.
The agency 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
The request was posted in the Federal Register on March 4, and the comment period will remain open for 60 days after that date.
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