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Remanufacturing of Medical Devices: New FDA Guidance for Industry and Service Providers

Issued: May 10, 2024 - Remanufacturing of Medical Devices


The medical device landscape is diverse and rapidly evolving, with products ranging from simple tools to complex machinery. Many of these devices are reusable, requiring routine maintenance and repairs to ensure their continued safe and effective operation. However, there has often been confusion in the industry regarding the distinction between "servicing" and "remanufacturing" of these devices. The U.S. Food and Drug Administration (FDA) has issued new guidance to clarify these terms and outline the regulatory responsibilities associated with each activity for the Remanufacturing of Medical Devices.


Understanding the Difference: Servicing vs. Remanufacturing of Medical Devices


Servicing involves routine maintenance and repairs necessary to keep a device in its intended operational condition. Remanufacturing, on the other hand, includes activities that significantly change the device’s performance, safety specifications, or intended use. This distinction is crucial because remanufacturing carries additional regulatory responsibilities.


The new guidance aims to help manufacturers, third-party service providers, and FDA staff determine whether their activities constitute remanufacturing. By providing clear definitions and examples, the FDA seeks to ensure consistent understanding and application of regulatory requirements across the industry.


Key Elements of the Guidance


  1. Definitions and Clarifications: The guidance provides detailed descriptions of what constitutes servicing and remanufacturing, helping entities to accurately classify their activities.

  2. Regulatory Implications: It outlines the regulatory obligations that come with remanufacturing, including the need for compliance with specific statutory and regulatory requirements. This includes possible re-submission for FDA approval if significant changes are made to the device.

  3. Labeling Recommendations: The FDA offers recommendations for information that should be included in device labeling. Proper labeling is essential to maintain the quality, safety, and effectiveness of devices throughout their useful life.

  4. Applicability: The guidance applies to all reusable medical devices, regardless of their classification (Class I, II, or III). It covers devices that require preventive maintenance and repair but does not address reprocessed single-use devices.


Implementation and Compliance

The guidance emphasizes that while it reflects the FDA's current thinking and recommendations, it does not establish legally enforceable responsibilities. Instead, it should be seen as a set of best practices for maintaining compliance with existing regulations.


For the most up-to-date standards referenced in the guidance, stakeholders are directed to the FDA Recognized Consensus Standards Database. The guidance also includes references to additional documents for more detailed information on using consensus standards in regulatory submissions.


Conclusion of Remanufacturing of Medical Devices guidance

The FDA’s new guidance on the remanufacturing of medical devices is a significant step towards ensuring clarity and consistency in the maintenance and repair of reusable medical devices. By distinguishing between servicing and remanufacturing, the FDA aims to help industry stakeholders better understand their regulatory responsibilities, ultimately ensuring the safety and effectiveness of medical devices for users.


Entities involved in the servicing or remanufacturing of medical devices should familiarize themselves with this guidance to ensure they are in compliance with FDA regulations and can continue to provide safe and effective products to the market.


For further information or assistance, industry stakeholders are encouraged to consult the FDA's comprehensive documentation and reach out to the agency with any questions or concerns.



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