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  1. Quality and Compliance (Medical Devices)

Remanufacturing and Servicing Medical Devices

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A remanufacturer is defined as any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use. [21 CFR 820.3(w)]. The FDA considers remanufacturing to be a distinct activity from servicing that raises different concerns, and is thus regulated differently.

The availability of timely, cost-effective, quality maintenance and repair of medical devices is critical both to the successful functioning of the United States (U.S.) healthcare system and to the continued quality, safety, and effectiveness of marketed medical devices in the U.S. This is very important for those devices used on numerous patients over long periods of time. Poor quality servicing may lead to poor device performance, device malfunction, and adverse events. Cybersecurity is also an important consideration in the servicing of medical devices.

Resources on Remanufacturing and Servicing

Draft Guidance

The distinction between "remanufacturing" and "servicing" is important to understand. Remanufacturing is the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device's performance or safety specifications, or intended use. Servicing is the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the original equipment manufacturer (OEM) and to meet its original intended use. Regardless of an entity's self-identified designation as a "servicer" or "remanufacturer," the FDA focuses on the specific activities an entity performs on a particular device. The determination of whether the activities an entity performs are remanufacturing affects the applicability and enforcement of regulatory requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations. The FDA enforces requirements under the FD&C Act and its implementing regulations on entities engaged in remanufacturing, including but not limited to registration and listing, adverse event reporting, the Quality System (QS) regulation, and marketing submissions.

Papers and Reports


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