Lexology June 5, 2024
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CDRH finalizes guidance addressing device remanufacturing and servicing.
- On May 9, 2024, the FDA Center for Devices and Radiological Health (CDRH) released a guidance document entitled, “Remanufacturing of Medical Devices.” This guidance aims to distinguish the types of activities that qualify as servicing rather than remanufacturing (which involves additional regulatory responsibilities).
- FDA defines remanufacture as follows: “Process, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.” Since these remanufacturing activities significantly change the device’s performance or safety specifications,...
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