While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for servicing performed by independent third parties.
The FDA issued its final guidance document on Remanufacturing of Medical Devices (Final Guidance) on May 10, 2024 to provide clarification on the difference between device “remanufacturing” and “servicing” activities. This distinction is significant as FDA generally does not require independent third parties (unrelated to the original equipment manufacturer) that only perform servicing activities to comply with its medical device regulatory requirements, whereas FDA does require full compliance for all entities (including third-party servicers) that perform remanufacturing activities.
Although FDA’s goal in providing clarity on remanufacturing was generally supported by industry stakeholders, the Final Guidance by itself is unlikely to fully assuage critics of FDA’s policies on third-party servicing, as it relies on third-party servicers to determine whether they have crossed into remanufacturing through self-assessment.
BACKGROUND
FDA’s lax enforcement policy for third-party servicers has come under scrutiny over the years, with many stakeholders raising concerns about the risks of device servicing in the absence of active FDA oversight. These concerns culminated in a requirement imposed by the 2017 Food and Drug Administration Reauthorization Act for the agency to issue a report on the quality, safety, and effectiveness of medical devices with respect to servicing.
FDA issued its report on medical device servicing in May 2018, in which it concluded that most of the complaints and adverse event reports that FDA had received for servicing activities actually involved remanufacturing activities, which FDA considered to be higher risk and for which FDA required full compliance with its medical device regulations. FDA’s reliance on reported events is somewhat questionable, however, particularly given that third-party servicers have no mandatory reporting obligations and thus any issues related to servicing were likely underreported. Based on its findings in the 2018 report, FDA committed to issuing a guidance document to clarify the distinction between servicing and remanufacturing.
Through this Final Guidance, FDA delivers on this commitment and continues to emphasize that remanufacturing activities, whether performed by an original equipment manufacturer (OEM) or a third-party servicer, must comply with FDA’s premarket and postmarket medical device regulatory requirements.
However, although several comments on the draft version of this guidance raised concerns with FDA’s continued hands-off approach for third-party servicing, the Final Guidance includes no clear reversal of this policy; thus, independent third parties (but not OEMs) performing only servicing activities continue to benefit from limited FDA oversight.
GUIDANCE PROVIDES MULTIPLE TOOLS FOR ASSESSING WHETHER AN ACTIVITY IS REMANUFACTURING
Under the Final Guidance, FDA defines the term “remanufacture” to mean “[p]rocess, condition, renovate, repackage, restore, or any other act done to a finished device that significantly changes the finished device’s performance or safety specifications, or intended use” (emphasis added).
The term “service” is defined to mean “[r]epair 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” (emphasis added). The term “service” also explicitly excludes “activities that significantly change the finished device’s safety or performance specifications, or intended use” (emphasis added).
FDA lists six “guiding principles” in the Final Guidance to help determine whether specific activities significantly change a device’s performance or safety specifications or intended use such that the activities qualify as 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
- Evaluate whether any changes to a device require a new marketing submission
- Assess component/part/material dimensional and performance specifications
- Employ a risk-based approach
- Adequately document decision-making
The Final Guidance also includes a flowchart for assessing whether activities are “remanufacturing” and lists several examples in the Appendix of different activities with an assessment of whether such activities qualify as servicing or remanufacturing.
FDA EMPHASIZES THAT REMANUFACTURING REMAINS ACTIVELY REGULATED, BUT IMPLEMENTATION CHALLENGES PERSIST
In the Final Guidance, FDA continues to emphasize that remanufacturers are considered manufacturers for purposes of FDA compliance, stating that “FDA has consistently enforced requirements under the [Federal Food, Drug, and Cosmetic Act] and its implementing regulations on entities engaged in remanufacturing.”
FDA also added to the Final Guidance a summary listing of the regulatory requirements that apply to remanufacturers, including establishment registration, device listing, premarket review, medical device reporting, reporting of corrections and removals, good manufacturing practices (as set forth in the quality system regulation), and device labeling (including unique device identifiers).
Although FDA confirms that it can take enforcement action against entities that perform remanufacturing without adhering to the above requirements, it is unclear how effective FDA’s oversight on this issue can be for third-party servicers. The Final Guidance relies on third-party servicers to self-assess whether their activities qualify as remanufacturing, and third-party servicers are not required to register with FDA and thus are not subject to routine FDA inspection.
Moreover, it is unclear whether and to what extent third-party servicers, who do not have access to the OEMs’ confidential device design and specification information, will be able to effectively assess the factors set forth in the Final Guidance for determining whether an activity “significantly changes the finished device’s performance or safety specifications” (such that it is remanufacturing) or instead merely returns the device “to the safety and performance specifications established by the OEM” (such that it is servicing).
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