The medical device industry operates under strict oversight, and the recent release of the FDA’s final guidance on remanufacturing of medical devices represents a very important development for manufacturers, service providers and component suppliers. This article explores the key elements of this guidance, its implications for the industry, and how companies like Oxus are leading the way to ensure compliance.
Overview of the FDA’s final guidance
On May 10, 2024, the FDA released the final guidance for remanufacturing of medical devices, setting clear expectations for manufacturers, entities performing servicing and service part suppliers. The guidance is a culmination of years of industry feedback and regulatory analysis, aimed at clarifying the boundaries between remanufacturing and refurbishing.
According to the guidance, an organization is remanufacturing a product unless it can demonstrate otherwise. This distinction is significant, as remanufacturers are viewed by the FDA in the same light as Original Equipment Manufacturers (OEMs). This means they are required to maintain an FDA-compliant quality system, achieve pre-market certification, implement a robust design and development process, conduct post-market surveillance, ensure proper registration for the device(s) as well as the facility and assign unique device identifiers, among many other requirements.
The guidance allows for and encourages the use of aftermarket components, including refurbishment of products, provided that the manufacturer can prove that the safety, efficacy and performance of the device remain unchanged. This includes the documented burden of proof for component suppliers, who must demonstrate QMS compliance preferably through ISO-13485 certification (incorporated by reference into the FDA QMSR beginning February 2, 2026), performance and safety testing results, risk assessments, risk mitigation strategies, amongst other requirements to meet the guiding principles.
Compliance and documentation: a new standard
For companies like Oxus, adhering to these new guidelines is not optional—it’s a necessary component of our operations. Oxus has long been committed to maintaining compliance with FDA regulations, and this new guidance is no exception. The company’s approach involves a strong risk management process, utilizing ISO standards such as ISO 14971 for risk assessment, and ensuring that all refurbished components meet the required safety and performance standards without impacting the intended use of the device.
One of the key aspects of compliance is documentation. Further to the documentation requirements previously mentioned, Oxus serializes every product, maintaining detailed records that can be traced back to its final test report data, manufacturing process, manufacturing date and important component information. This level of traceability is not optional for passing audits. Although the FDA may not conduct regular audits of refurbishers, they reserve the right to conduct “for cause” audits at any time to ensure that companies are adhering to the guidance.
Protecting partners from liability
Oxus’s proactive approach to compliance extends to its partners. By adhering to the FDA’s guidance, Oxus helps protect its partners from potential liability and regulatory exposure. The company’s components and contract manufacturing services are fully compliant with the new FDA guidance, and they are regularly audited by the FDA to ensure ongoing adherence to these standards.
The FDA’s guidance documents, while not legally binding, describe the agency’s current thinking on specific topics. They must be taken seriously, as failure to comply can result in audits and inspections if evidence suggests that the guidance is not being followed.
Looking ahead: the 2026 transition
The industry is also preparing for the 2026 deadline, which marks the transition to new quality management system requirements (QMSR). With the incorporation by reference of ISO-13485 into the FDA QMSR, having and maintaining a strong Quality System is more important than ever. Oxus has maintained ISO 13485 certification since 2011, positioning the company to meet the forthcoming changes without disruption. The focus now is on ensuring that all documentation and processes are aligned with both the existing and new standards.
While the 2026 deadline may seem distant, the importance of early preparation cannot be overstated. Companies that wait until the last minute to adapt to these new requirements may find themselves struggling to comply, risking audits, fines and reputational damage.
Conclusion
The FDA’s final guidance on remanufacturing of medical devices is a significant regulatory development that will have lasting implications for the medical device industry. Companies like Oxus, which have already embraced these changes and integrated them into their operations from the beginning, will be better positioned to navigate the complexities of regulatory compliance.
By maintaining strict adherence to FDA guidelines, investing in thorough testing, documentation and protecting their partners from liability, Oxus exemplifies the proactive approach needed to succeed in this highly regulated industry. As the industry moves toward the 2026 transition, the emphasis on compliance and preparation will only grow, making it imperative for all stakeholders to stay informed and take timely action.