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.1 This guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.” Such clarification is intended to help provide consistency and better understanding of applicable statutory and regulatory requirements.
This guidance also 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. In developing this guidance, FDA considered objective evidence and information learned from the Agency’s activities discussed in this guidance.
For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices” and “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research.” In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.