FDA Final Guidance on Remanufacturing of Medical Devices

The distinction between “servicing” and “remanufacturing” has often caused confusion throughout the medical device industry. Consequently, earlier this year the FDA issued a Final Guidance Document titled “Remanufacturing of Medical Devices” in order to clarify which activities qualify as servicing and which activities qualify as remanufacturing. This is a critical distinction as remanufacturing falls under many of the specific regulatory requirements applicable to medical devices.

The FDA defines remanufacturing as “the processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use.” The key is to distinguish such activities from repairs and maintenance work which is considered a servicing activity.

The Guidance Document lays out six guiding principles that should be assessed in differentiating servicing from remanufacturing:

• Assess whether there is a change to the intended use
• Determine whether the activities, individually and cumulatively, significantly change the safety or performance specifications of a finished device, including activities which enhance the device
• Evaluate whether any changes to a device require a new marketing submission – changes that qualify as remanufacturing could trigger a 510(k), PMA, or other marketing submission depending on the risk-based classification
• Assess component/part/material dimensional and performance specifications
• Employ a risk-based approach, such as one that confirms with ISO 14971: “Medical devices – Application of risk management to medical devices”
• Adequately document decision-making which will be crucial when justifying the conclusion in the event of an FDA inspection or request

These guiding principles are described in significant detail within the document to assist stakeholders with their assessments. Additionally, the FDA includes a flow chart to help guide the evaluation process. Adequate documentation of the justification for the conclusion should include the following, at a minimum:

• Product name (including model number and serial number, if applicable)
• Date of activities performed, assessment, and determination
• Description of device
• Description of activities to be performed, including documentation of components/parts/materials involved
• Determination of whether the activity is remanufacturing
• Reference to related documents supporting the decision-making process
• Signature(s)

Examples of such documentation are included in Appendix B of the Guidance Document.

Remanufacturers are considered manufacturers under the FD&C Act and FDA’s regulations, and are therefore regulated accordingly. Organizations that are remanufacturing devices, including devices that they did not originally manufacture, are generally subject to the same regulatory requirements as the OEM of the device.

To provide further clarity to medical device companies, the FDA will be hosting a webinar on September 10, 2024 for anyone interested in hearing more about this topic.

If anyone would like a link to the webinar, please reach out. If you need any assistance with a remanufacturing assessment or with any regulatory or quality matters for your medical devices, please contact us at PRP. We understand how challenging it can be to maintain compliance while managing your day-to-day operations. Our experienced Med Device QA/RA consultants can seamlessly integrate with your team to fill any gaps in expertise or bandwidth, ensuring you stay on track with your compliance goals. We would welcome the opportunity to work together!