FDA Update –

Remanufacturing of Medical Devices – Guidance for Industry

The U.S. Food and Drug Administration (FDA) has recently released a guidance document that directly affects our industry: Remanufacturing of Medical Devices – Guidance for Industry.

The guidance aims to provide clarity on what actions performed are considered “remanufacturing.” The FDA intends to provide a better understanding of the statutory and regulatory requirements as well as recommendations for quality, safety, and effectiveness.

Defining Remanufacturing: A Closer Look

• Significant Change: The term “significant change” is crucial in determining whether an activity constitutes remanufacturing. It’s not just about the magnitude of the change but also its impact on the device’s intended use, performance, or safety.
• Examples of Remanufacturing: Some examples of activities that could qualify as remanufacturing are:
  • Replacing or modifying critical components that significantly alter the device’s function.
  • Reprocessing or reconditioning a device to restore its original performance after it has been used or damaged.
  • Changing the intended use of a device to a different clinical application.
• Distinction from Servicing: Servicing involves repairing or maintaining a device to restore its original safety and performance specifications. While servicing is essential, it does not typically constitute remanufacturing.

Determining Remanufacturing Status

• Evaluation Criteria: The guidance outlines specific criteria to help determine if an activity qualifies as remanufacturing. These include:
  • Change in performance or safety: Does the activity significantly alter how the device functions or its safety profile?
  • Change in intended use: Does the activity modify the device’s intended purpose or application?
  • Cumulative effect: Even if individual activities may not seem significant, their combined effect could result in remanufacturing.

Regulatory Requirements: Beyond Premarket Notification

• Premarket Notification: Remanufacturers may need to submit premarket notifications to the FDA, depending on the nature of the changes made to the device.

• Quality System: Adhering to a robust quality system is essential for remanufacturers. This includes:
  • Design and development controls: Ensuring that the remanufactured device meets the same design and performance requirements as the original.
  • Manufacturing and production controls: Implementing processes to ensure consistent quality and safety.
  • Complaint handling: Having a system in place to promptly investigate and address complaints.
• Labeling: Remanufactured devices must have clear and accurate labeling that indicates that they are remanufactured and provides all necessary information for safe and effective use.

Ethical Considerations

• Patient Safety: Remanufacturers must prioritize patient safety throughout the process. This includes:
  • Risk assessment: Identifying and mitigating potential risks associated with remanufacturing.
  • Traceability: Ensuring that devices can be traced throughout their lifecycle.
  • Ethical sourcing: Avoiding the use of counterfeit or substandard components.
• Environmental Impact: Remanufacturing can have a positive environmental impact by reducing waste and conserving resources. However, remanufacturers should also consider any potential environmental risks associated with their processes.

Additional Considerations

• Device-Specific Factors: The guidance recognizes that the definition of remanufacturing may vary depending on the specific type of medical device.
• Collaboration with OEMs: In some cases, collaboration with the original equipment manufacturer can help clarify the boundaries between servicing and remanufacturing.

In summary, this guidance document aims to provide a clear understanding for facilities who engage in the remanufacturing process.

Should you have any questions or require further information, please do not hesitate to reach out to us. Your success and satisfaction remain at the forefront of our endeavors.

For the original update, please visit the FDA’s website.

We are dedicated to navigating this process diligently, underscoring our unwavering commitment to you, our valued clients. As always, your trust in mdi Consultants drives us to continually improve and deliver excellence in every aspect of our operations.

Questions?

For any further questions regarding the remanufacturing of medical devices, as well as assistance in this process, please email mdi Consultants at [email protected] RE: Remanufacturing.