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FDA service and remanufacturing draft guidance: key takeaways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

A useful analysis flow chart
The FDA offers a useful flowchart to further assist in discerning whether the activity is servicing or remanufacturing. Consistent with its 2019 white paper, Guidance Coversheet – CDRH Level 1 DRAFT (fda.gov), the FDA recommends the use of this flow chart (see Guidance Figure 1). This flowchart helps determine if the activity is likely "remanufacturing". This visual aid traces the analysis which ought to be adopted. Note: the FDA excepts from the use of this flowchart the evaluation of software. As the FDA observes, due to the nature of software and the methods used to evaluate changes to software the flowchart should not be used.

Document, document, document

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The FDA states in the guidance at several points that one should document the decision-making process determining whether the activity is remanufacturing or not. The language of the guidance requires that one document the basis for the determination as to whether the cumulative effects of the activities being undertaken constitute "remanufacturing". For some, this may require some change in servicing protocols and paperwork.

The guidance describes the documentation process in a somewhat foreboding manner: “[t]he documentation should be prepared in a way that an FDA investigator or other third party can understand what the change was and the rationale underlying the conclusion.” This includes that the documentation at a minimum should include: the product name (model number and serial number), date of activities performed, assessment and determination, description of the device, description of activities to be performed, determination of whether the activity is remanufacturing, reference to related documents supporting the decision-making process and signatures. Appendix B to the guidance provides specific examples.

An upcoming webinar may provide more answers
While the FDA webinar scheduled for July 27 may offer further assistance, it would seem that questions will understandably remain as to whether the insertion of certain compatible parts, not from the OEM but another vendor, will be deemed to be "remanufacturing". By way of possible example, if a circuit board is improved with certain parts and results in overall improvement of the device’s performance, does such activity constitute a "significant change" to device performance and safety such that this improvement would constitute remanufacturing? The draft guidance seems to suggest that such activity, even if an improvement, could constitute remanufacturing.

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