Remanufacturing 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.” In contrast, servicing 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 [original equipment manufacturer] and to meet its original intended use.”

In June 2021, FDA issued draft guidance on “Remanufacturing of Medical Devices,” aiming to help clarify the point when manipulation or repair of a medical device becomes “remanufacturing” as opposed to “servicing,” with the former designation carrying significant regulatory impact. As we analyzed online here, the draft guidance recommended using the following six guiding principles when determining whether activities are “remanufacturing”:

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 require a new marketing submission;

4. Assess component/part/material dimensional and performance specifications;

5. Employ a risk-based approach; and

6. Adequately document decision-making.

The final guidance kept these six guiding principles intact. It also added five pages of recommendations on the “regulatory requirements and considerations for remanufacturers,” addressing the following topics:

• Establishment Registration and Medical Device Listing. The final guidance clarifies that remanufacturers are required to obtain their own device listing, independent of OEM’s device listing, and their own establishment registration if not already registered as a device manufacturer.

• Marketing Authorization. Remanufacturers are responsible for complying with premarket requirements, including obtaining the required FDA marketing authorization prior to conducting remanufacturing activities on the OEM’s legally marketed finished device. The final guidance clarifies: “The relevant regulatory standard must be met for remanufactured devices, which have experienced a significant change to performance or safety specifications, or intended use, as compared to the OEM’s legally marketed finished device.”

• Medical Device Reporting. The final guidance cautions that, as manufacturers, remanufacturers are responsible for reporting adverse events and certain malfunctions. They are required to report to FDA when they learn that any of their devices may have caused or contributed to a death or serious injury, and must also report to FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

• Reports of Corrections and Removals. Remanufacturers are responsible for taking action and reporting to FDA any correction or removal which was initiated to reduce a risk to health posed by the device or to remedy a violation of the FDCA caused by a device that may present a risk to health. And the final guidance reminds remanufacturers that even if they are not required to report such a correction or removal of a device to FDA, records of such actions must be kept.

• Quality System. Remanufacturers of medical devices are required to have a quality system in place for their device, unless the device is exempt from good manufacturing practices (GMP) requirements. The QS Regulation (QSR) includes requirements related to the methods used in and the facilities and controls used for: designing, purchasing, manufacturing, packaging, labeling, storing, installing, and servicing of medical devices.

• Labeling. The final version of the guidance highlights that remanufacturing activities that significantly change the performance or safety specifications of a device, or its intended use, are likely to require corresponding FDA labeling changes. FDA offers the example that when “a remanufacturer adds a feature or function to a reusable device,” that “modification would necessitate labeling changes to provide adequate instructions for how to use the new feature or function and to the associated reprocessing instructions to ensure the device can be reused safely and effectively with the new feature or function.” The final guidance adds: “It is the responsibility of the remanufacturer to modify and validate any necessary labeling changes that are associated with the specific remanufacturing activity including, but not limited to, the remanufacturer identifying information, obtaining a new UDI, and modifying directions for use, device specifications, and warnings as needed.”

The final guidance retains the draft version’s flowchart that can help manufacturers determine if their changes are qualified as remanufacturing or not, but separately emphasizes that the flowchart does not apply to “software changes,” which have different definitions of servicing and remanufacturing. With the final guidance’s appendix only containing three examples of what would be deemed “remanufacturing” for software, the line between “servicing” and “remanufacturing” for software remains unclear in some cases. And this distinction carries significant implications, including whether and when the obligations of a medical device manufacturer are triggered, including:

• Whether a new marketing submission is required;
• MDR reporting (for both the remanufacturer, and the OEM if they become aware of a reportable event);
• Registration and listing;
• QSR compliance;
• Removals or corrections obligations and reporting; and
• General adulteration and misbranding prohibitions

The guidance is predicated on the entity performing the work doing an analysis of whether their work affects the devices’ performance or specifications as already established by the OEM; some of which are publicly available at a high level, but many of which are not. Further, it requires the entity to compare the impact of its work based on risk, which is usually articulated in the OEM’s risk management file, which again are documents that usually are not publicly available. While a entity providing service may be willing to perform the evaluation, it will likely be difficult to know what the standard is against which they are making the comparison, especially where the changes are seemingly changing like for like, but may actually have a meaningful impact. For example, where an entity is changing out a failing PCBA that was designed specifically by the OEM for that device with an after market PCBA that meets the high level specification, but may not have been specifically designed for the medical device application, it may be difficult to appreciate the extent and impact of the differences.

FDA explains in the Final Guidance that “modifying the design of a printed circuit board or temporarily breaking a seal to replace a component, may result in a significant change to safety and performance specifications and should be carefully assessed to determine if those changes are significant.” Thus, where third parties perform their activities in collaboration with the OEM, or only use OEM parts, this analysis may be fairly easy, but where the third parties are wholly independent of the OEM or are using OEM parts of unknown quality, the analysis described by FDA may be very difficult or impossible to perform well. That said, this guidance articulates the agency’s position and sets forth the agency’s expectations that entities performing these activities generate such an analysis. We suspect nevertheless that they will be vulnerable to future challenges by the agency when or if after-servicing performance differences or heightened risks are observed because the baseline specifications and performance standards to which the devices are designed are closely held by the OEMs.

Next steps

Service providers should perform the evaluations of the impact of their work on devices as to whether it constitutes remanufacturing or servicing. OEMs should continue to monitor complaints that they believe are rooted in servicing work and consider performing their own analysis as to the impact of the service work related to specifications and/or performance and consider whether there are opportunities to address unauthorized servicing. In either situation, we can help you analyze your circumstances and develop your plans.

Additionally, FDA will host a webinar on the final guidance on June 27. If you may wish to attend, or have any questions on remanufacturing of medical devices, please contact any of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.