By Robert J. Kerwin
On June 18, 2021, the FDA released its long-awaited draft guidance entitled Remanufacturing of Medical Devices.
The 17-page document contains two appendices of examples and addresses both devices and software.
The draft guidance, which does not apply to single-use devices and is not intended to include significant policy changes, aims to help clarify which activities performed on devices are likely to be deemed “servicing” and what activities are deemed to be “remanufacturing”. Although the guidance was issued with the disclaimer that it does not establish any rights for any person and is not binding on the FDA, thoughtful industry observers would counsel all stakeholders to take the guidance’s suggestions seriously.
“I would generally be wary of deviating from any of the recommended practices in an FDA Guidance, and in the event I deviated, I would ensure I could document that such deviation achieved an equally appropriate approach," said Stephen Grimes, principal consultant at Strategic Healthcare Technology Associates.
Why did the FDA issue a guidance on remanufacturing?
The determination of whether a medical device activity is "servicing" or "remanufacturing" has regulatory consequences for the party performing the activity on the medical device. A determination that the activity is "remanufacturing" requires the servicer to take on certain manufacturer responsibilities.
In recent years, the FDA had made considerable efforts to gain perspectives on "servicing" and "remanufacturing". These include an extensive review of the 2016 FDA public docket and the conducting of a two-day servicing industry workshop. However, in recognition of continued industry confusion on what constitutes "remanufacturing", the FDA committed in the 2018 report to issue a remanufacturing guidance, noting that the majority of the comments, complaints and adverse event reports received in connection with the preceding docket and public workshop on servicing actually referred to "remanufacturing" activities.
‘Remanufacturing’ significantly changes the device
In the remanufacturing guidance, the FDA first states that “[s]ervicing is the repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the safety and performance specifications established by the OEM and to meet its original intended use.” This "servicing" definition was tweaked slightly to remove "remanufacturing" from the FDA’s definition of servicing found in its 2018 Report. By this slight change, the FDA has acknowledged that “remanufacturing” is not, in the FDA’s view, a form of servicing.
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.”
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”.
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
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.
Many software changes are likely remanufacturing but…
The FDA notes that many software changes are likely "remanufacturing" because of their impact on the product’s software architecture and performance. However, the guidance also provides that certain activities are not generally considered to be a change in performance, such as implementing OEM-provided updates and assessing for cybersecurity-related issues.
Accessing diagnostic and repair information and performing data backup and recovery operations are also recognized as not constituting "remanufacturing". Section VII on software is worth a read as it lists 13 software activities not deemed to be "remanufacturing".
FDA encourages OEMs to share instructions
The guidance makes clear that devices should “include instructions on how to adequately return a device to its performance and safety specifications established by the OEM.”
It notes that Section 502(f)(1) of the Federal Food Drug and Cosmetic Act requires that labeling bear adequate instructions for use. Were this admonition not sufficiently clear, the FDA further states, “[c]onsistent with promoting and protecting the public health, FDA encourages OEMs, as an industry best practice, to provide servicing instructions that facilitate routine maintenance and repair of their reusable devices.”
The list of items which are encouraged to be provided include "a description of error codes, alerts and alarm features on a device."
“All in all, the draft guidance offers many important answers to long outstanding questions and suggests some important courses of cooperation toward the mutual goal of patient health," said Diana Upton, president of IAMERS. "It is worth careful review by equipment servicing stakeholders.”
Of course, the draft guidance is not the FDA's final word on this subject. Comments on this draft guidance can be submitted within 60 days.
About the author: Robert J. Kerwin is the general counsel for the International Association of Medical Equipment Remarketers and Servicers (IAMERS).