FDA clarifies the distinction between device remanufacturing and servicing in final guidance publications

While the U.S. Food and Drug Administration’s recent Final Guidance on Medical Device Reprocessing provides clarity and attempts to regulate certain activities, the agency continues to defer enforcement for services provided by independent third parties.

On May 10, 2024, the FDA issued final guidance on the reprocessing of medical devices (Final Guidance) to clarify the difference between “reprocessing” and “servicing” activities. This distinction is important because the FDA generally does not require independent third parties (unrelated to the original equipment manufacturer) that merely perform activities servicing operations to meet regulatory requirements for medical devices, while the FDA requires full compliance from all entities (including third-party service providers) that perform regeneration classes.

Although the FDA’s goal of providing transparency regarding remanufacturing has been generally supported by industry stakeholders, the final guidance alone is unlikely to fully assuage critics of the FDA’s third-party servicing policy because it relies on third-party servicers to determine whether they entered regeneration through self-assessment.

BACKGROUND

Over the years, the FDA’s lax enforcement policy toward third-party servicers has come under scrutiny, with many stakeholders expressing concerns about the risks of servicing devices in the absence of active FDA oversight. These concerns led to a requirement imposed by the Food and Drug Administration Reauthorization Act of 2017 that the agency issue a report on the quality, safety and serviceability effectiveness of medical devices.

The FDA released its report on medical device servicing in May 2018, which found that most of the complaints and adverse event reports the FDA received related to servicing actual activities involved regeneration activities that the FDA deemed higher risk and for which the FDA required full compliance with its medical device regulations. FDA’s reliance on reported events, however, is questionable, especially considering that third-party servicers have no mandatory reporting obligations and therefore any service-related issues were likely under-reported. Based on the findings of the 2018 report, the FDA committed to issuing guidance clarifying the difference between servicing and remanufacturing.

In this Final Guidance, FDA honors its commitment and continues to emphasize that remanufacturing activities, whether performed by an original equipment manufacturer (OEM) or a third-party service company, must comply with regulatory requirements FDA pre-market and post-market medical device regulations.

However, although several comments on the draft of this guidance raised concerns about FDA’s continued hands-off approach to third-party servicing, the Final Guidance does not contain an explicit reversal of this policy; therefore, independent third parties (but not OEMs) engaged solely in service activities continue to benefit from limited FDA oversight.

THE GUIDELINES PROVIDE MANY TOOLS TO ASSESS WHETHER AN OPERATION IS RECOVERY

According to the final guidance, the FDA defines the term “remanufacturing” as ”

The term “service” is defined as “(r)epair and/or preventive or routine maintenance of one or more parts of a finished device, after distribution, to restore it to the safety and performance specifications established by the OEM and to its original intended use” (emphasis added). The term “service” also expressly excludes “activities that significantly change the safety, performance or intended use specifications of the finished device” (emphasis added).

The FDA lists six “guiding principles” in the final guidance that help determine whether certain activities significantly alter a device’s performance, safety specifications, or intended use such that the activities qualify as remanufacturing:

1. Assess whether there is a change in intended use
2. Determine whether the actions, individually and in the aggregate, significantly change the safety or performance specifications of the finished device
3. Evaluate whether any device changes require a new marketing notification
4. Evaluate the dimension and performance specifications of the component/part/material
5. Take a risk-based approach
6. Document decision making appropriately

The final guidance also includes a flowchart for assessing whether activities constitute “remanufacturing” and in the Annex lists several examples of different activities along with an assessment of whether such activities qualify as servicing or remanufacturing.

FDA EMPHASIZES THAT REGENERATION REMAINS ACTIVELY REGULATED, BUT IMPLEMENTATION CHALLENGES PERSIST

In the Final Guidance, FDA continues to emphasize that reprocessors are considered manufacturers for FDA compliance purposes, stating that “FDA consistently enforces the requirements under the (Federal Food, Drug, and Cosmetic Act) and its implementing regulations with respect to to entities dealing with regeneration. ”

FDA also added to the Final Guidance a summary of regulatory requirements applicable to reprocessors, including facility registration, device inventory, premarket review, medical device reporting, reporting of corrections and deletions, good manufacturing practices (in accordance with the quality system regulation), and labeling products (including unique product identifiers).

While the FDA acknowledges that it may take enforcement action against reprocessors without complying with the above requirements, it is unclear how effective FDA oversight of this issue could be for third-party servicers. The final guidance relies on third-party servicers making their own assessment of whether their activities qualify as remanufacturing, and third-party servicers are not required to register with the FDA and therefore are not routinely subject to FDA inspection.

Moreover, it is unclear whether and to what extent third-party servicers, who do not have access to confidential information about OEM device designs and specifications, will be able to effectively evaluate the factors set out in the Final Guidance for determining whether an activity “significantly alters the performance or safety specifications of the finished device” (such as it is a remanufacture), or instead simply restores the device “to the safety and performance specifications established by the OEM” (such as serviceability).