FDA Defines Device ‘Remanufacturing’
FDA has published a final guidance, Remanufacturing of Medical Devices, to clarify for the medical device industry the definition of “remanufacturing” for reusable medical devices needing maintenance or repair. The document says there has been a lack of clarity about the distinction between “servicing” and “remanufacturing” of a device. “Most notably,” it says, “remanufacturing has implications for the regulatory responsibilities of entities performing these activities.”
An accompanying statement says the guidance was issued following the agency’s review of postmarket information and consideration of public comments, which highlighted the need for clarity, considering the different regulatory implications between “servicing” and “remanufacturing” of a medical device.
According to the guidance, 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, safety specifications, or intended use. Servicing, it says, is considered to be 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 and to meet the original intended use.
“The final guidance sets forth guiding principles that 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,” FDA says. The document also recommends certain information to 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 original manufacturer.
The guidance includes an Introduction, Background, Scope. Definition, Guiding Principles, Relevant Considerations to Determine if Activities are Remanufacturing, Changes Involving Software, Regulatory Requirements and Considerations for Remanufacturers, and two Appendices.