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FDA releases guidance on ‘remanufacturing’ of devices 

May 13, 2024HME News Staff

WASHINGTON – The U.S. Food and Drug Administration has issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The final guidance was issued following the agency’s extensive review of post-market information and consideration of public comments, which highlighted the need for clarity, considering the different regulatory implications between “servicing” and “remanufacturing”...

Maintenance, remanufacturing, Repair

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