The FDA has issued “final guidance to provide the medical device industry clarity on the definition of ‘remanufacturing’ for reusable devices needing maintenance or repair.” The agency issued a press release regarding the guidance.
This guidance is specifically meant to “ensure that there is consistency regarding what constitutes remanufacturing activities and to promote a better understanding of applicable federal law and regulations implicated by remanufacturing activities.” The agency observed “the need for clarity” when “considering the different regulatory implications between ‘servicing’ and ‘remanufacturing’ of a medical device.”
The FDA is recommending in this guidance that “devices include instructions necessary for proper device servicing, as well as providing examples of activities that constitute remanufacturing.” This will hopefully reduce improper servicing and unintentional remanufacturing.
Remanufacturing is “when a significant alteration is made to a device’s performance, safety specifications or its intended use, changing the device from what was legally marketed as approved, cleared or authorized by the FDA.”
The final guidance “sets forth guiding principles that the FDA recommends applying in the context of remanufacturing, a flowchart to help determine whether activities may be remanufacturing, and examples that may be helpful to industry.” It also “recommends certain information be included in the labeling of reusable medical devices regarding their preventive maintenance and repair, including instructions on how to adequately return a device to its performance and safety specifications established by the OEM.”
