FDA: Final Guidance on “Remanufacturing“ of Medical Devices
The FDA has issued final guidance clarifying "remanufacturing" for reusable medical devices needing maintenace or repair, aiming for consistency and better understanding of federal laws.
The guidance distinguishes between "servicing" and "remanufacturing". „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 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.“
The FDA recommends labeling information for preventive maintenance and repair, without disclosing trade secrets. Third-party servicers are recognised, with the FDA stressing the importance of quality servicing.
These efforts stem from a 2016 initiative to address industry concerns, culminating in today's guidance to ensure continued patient access to safe and effective medical devices.
Source:
FDA: FDA News Release
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