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FDA service and remanufacturing draft guidance: key takeaways

June 23, 2021
Parts And Service
From the August 2021 issue of HealthCare Business News magazine

Relying upon the definition of remanufacturing found in 21 C.F.R. 820.3 (w), the FDA affirmed that “[r]emanufacturing is 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.”

Guiding principles
Understanding that the "remanufacturing" and "servicing" definitions by themselves do not address all of the activities, the FDA suggested six guiding principles to be applied:

1. Assess whether there is a change to the intended use.
2. Determine whether the activities, individually and cumulatively, significantly change the safety or performance specifications of a finished device.
3. Evaluate whether any changes to a device required a new marketing (510k notification) submission.
4. Assess component/part/material dimensional and performance specifications.
5. Employ a risk-based approach.
6. Adequately document decision-making.

The FDA noted that what constitutes "significant changes" to a device, after verification/validation testing and risk-based assessments, is ultimately whether the finished device is “outside the OEM’s performance or safety specification or introduces new risks.” The FDA emphasized, for example, a change to material that has contact with the human body and impacts the adequacy of the OEM-validated reprocessing instructions is likely a significant change to device performance or safety specifications and therefore, is likely remanufacturing. In contrast, the FDA noted that replacing an internal capacitor with one that has the same specifications is likely not a significant change in performance and is likely not remanufacturing.

What deviations in component part/material specifications make the activity remanufacturing?
Though the draft guidance and its appendices attempt to clarify activities for which confusion previously existed, questions remain as to using compatible replacement parts from another manufacturer and whether such use makes the activity a remanufacturing event or may it still be construed as servicing? The contrasting examples in Appendix A to the guidance of changing the door of an infusion pump (not remanufacturing) and changing the rotor within a peristaltic infusion pump no longer supported by the OEM (remanufacturing) offer some clarification.

As 2018 AAMI BMET of the Year Scot Mackeil observed, “the guidance is clarifying and moving things in the right direction, but there are important concepts which could be further flushed out”.

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