Keeping up with FDA regulations can be difficult, especially when it comes to medical device components. The industry has been affected by the FDA’s new guidance on remanufacturing and servicing medical devices, which has raised the bar for service providers and component suppliers. In addition to welcoming these developments, Oxus has designed its systems and procedures to not only meet but exceed these standards. Because of this dedication, our partners can be sure that the components they receive from us are what they deserve.
Understanding the FDA’s new update
The FDA has clarified its position on remanufacturing versus refurbishment, emphasizing that unless proven otherwise, organizations providing aftermarket components for medical devices are considered remanufacturers. This distinction carries significant weight, as remanufacturers are held to the same stringent regulatory standards as OEMs including FDA registration.
The good news is that component suppliers would have a much easier time if they could prove they were refurbishing rather than remanufacturing. However, to claim refurbishment status, a component must pass testing and be carefully documented to show that its performance, safety and intended use of the top-level device have not changed. Oxus has accepted this challenge by doing exhaustive testing and critical risk mitigation documentation to demonstrate with confidence that our components are refurbished. This method detects and mitigates any risks, ensuring that the finished medical device is meeting performance standards, working safely, and not impacting the intended use of the device. It is founded on the industry-standard ISO 14971 risk management standards.
Remanufacturing vs. refurbishing of medical devices
Remanufacturing
According to the FDA, remanufacturing is the following:
“A remanufacturer is any person who processes, conditions, renovates, repackages, restores or does any other act to a finished device that significantly changes the finished device’s performance or safety specifications or intended use.”
Remanufacturing involves significant updates or modifications to a device’s performance or safety features, such as upgrading software or redesigning parts. It can fundamentally alter how the device functions or even its intended use.
The FDA keeps a close eye on remanufacturing, because these changes can affect the device’s safety or effectiveness. The FDA has the authority to look into any component supplier or
servicer and conduct “for cause” audits in order to confirm that they are not, in fact, remanufacturing.
Refurbishing
Refurbishing is more about restoring a device to its original condition. This could include cleaning, correcting cosmetic issues or replacing worn-out parts to make the device like new again, anything that does not make a significant change.
The FDA defines refurbishing as the following:
“Restores a medical device to the OEM’s original specifications comparable to when new. The device is brought to current specifications if the change(s) made to the device do not significantly change the finished device’s performance or safety specifications or intended use. These activities include repair of components, installation of OEM provided updates and upgrades and replacement of worn parts.”
Since refurbishing doesn’t change the intended use, safety, or performance of the device, it’s seen as less risky by the FDA. While the FDA would prefer to regulate refurbishment establishments, they understand they do not have the staffing for it. Therefore, they rely on the refurbishers to meet or exceed the original specifications all while maintaining the FDA QMSR requirements.
Documentation
The FDA’s main concern, whether it’s remanufacturing or refurbishing, is that the device remains safe and effective to ensure end-user and public safety.
Remanufacturers and Refurbishers both have high compliance standards, including detailed design controls and risk management. Remanufacturers add registration requirements and potentially submitting new approvals for the updated device. Just make sure to prove and document that no significant changes are made to the device’s performance, intended use or safety features.
Both refurbishers and remanufacturers must carefully document each action they do when processing the components, including testing and inspections.
For accountability and traceability, these documents are important.
QMSR and QSR transition
The FDA is transitioning from the current quality system regulation (QSR) to the quality management system regulation (QMSR) in February 2026. The QMSR incorporates by reference the internationally recognized ISO 13485:2016 standard.
This transition aligns U.S. regulations with global standards, streamlining the regulatory process and promoting uniformity across the industry. For U.S.-based medical device manufacturers, this change represents a significant step towards international alliance.
Impacts of the transition
While the QMSR is based on ISO 13485, it’s important to note that it is not a straight replacement. The FDA will continue to have special standards beyond ISO 13485. As a result, producers must become familiar with both standards and prepare for particular FDA regulations.
Under the existing QSR, the FDA limits the inspection of certain internal documents such as Management Review reports, meeting minutes and internal quality audit reports. This exemption allowed companies to discuss these matters openly without fear of government scrutiny.
This exemption is eliminated by the new QMSR, which is in line with ISO 13485:2016 standards, which do not protect this data from examination. This suggests that, like other regulatory agencies and auditors, the FDA will now be able to examine these documents.
Device manufacturers should therefore begin getting ready for this shift by updating the way they record their audit reports, management review reports and meeting minutes. It’s critical to make sure these materials are truthful and free of unnecessary commentary that can lead to misunderstandings.
Oxus’ approach
At Oxus, we recognize the importance of FDA guidelines, even though they are not legally binding. We ensure full compliance, viewing these recommendations as important standards.
Elements of our compliance strategy include:
● Quality management system (QMS): We operate under an ISO 13485 certified QMS. Our system is designed to meet both the current QSR and the upcoming QMSR for 2026.
● Risk management: A risk management process aligned with ISO 14971 principles ensures that all potential hazards are identified, analyzed and controlled.
● Testing: To guarantee that they fulfill the intended use requirements set out by the original manufacturer, we test every reconditioned component. Our components operate dependably and securely in the field thanks to our dedication to quality.
● Organized documentation: Device history records are among the documents we save. Thanks to our technology, every component has full traceability.
● Preparedness for “For Cause” audits: We know that the FDA has the authority to conduct “For Cause” audits to verify compliance with their guidance. Our audits are always ready, ensuring that our documentation, processes and records are transparent and available for inspection.
DME manufacturers face increasing FDA scrutiny on supply chains, making compliance more challenging. Partnering with Oxus helps reduce regulatory risks while ensuring the safety and effectiveness of medical devices.
Our regulatory experts simplify FDA compliance, providing quality-compliant parts and reducing your burden. With Oxus, you gain peace of mind, and a trusted partner committed to excellence.