Remanufacturing of Medical Devices Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff May 2024

GUIDANCE DOCUMENT

• Docket Number: FDA-2018-N-3741
• Issued by: Center for Devices and Radiological Health; Center for Biologics Evaluation and Research

Medical devices encompass a vast array of products with different technologies, product lifecycles, complexity, intended users, and environments of use. Many devices are reusable and need preventive maintenance and repair during their useful life. For these devices, proper servicing is critical to their continued safe and effective use. However, there is a lack of clarity regarding the distinction between "servicing" and "remanufacturing" of a device. Most notably, remanufacturing has implications for the regulatory responsibilities of entities performing these activities.

This final guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.”  This final guidance also clarifies existing regulatory requirements for remanufacturers and includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. 

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