By Alan Minsk
Reading the U.S. FDA’s recently issued Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff brings to mind the 1980s British rock band The Fixx, particularly their cautionary anthem, “Red Skies at Night.” This guidance serves as a warning to those involved in the servicing of medical devices, emphasizing the need for vigilance and adherence to regulatory frameworks.
Medical devices are an indispensable part of the U.S. healthcare industry, encompassing technologies that range from products as simple as tongue depressors to high-tech diagnostic machines. While many devices are single use, others that have long lifespans are used repeatedly, necessitating regular preventative maintenance and repair throughout their service life.
Servicing medical devices is critical to their proper usage, but some industry groups raised concerns about the quality of servicing provided by third-party entities that are not regulated by the FDA. As a result, the FDA developed this guidance to provide a framework for classifying activities performed by entities as “servicing” or “remanufacturing” of reusable medical devices.
Activities that constitute significant changes are considered remanufacturing, not servicing. Furthermore, if companies are engaged in remanufacturing, they could be subject to the same regulatory obligations as the original manufacturer, including marketing submissions and reporting requirements. The guidance is not legally binding and offers the FDA’s current thinking on the subject. Therefore, affected parties should review the guidance.
Background
Over the years, the FDA found that there was some industry confusion between remanufacturing and servicing, which prompted it to hold an October 2016 public workshop on remanufacturing and servicing. Following a public comment period, the FDA concluded in a 2018 report on device servicing that most clinical adverse events and deaths believed to be caused by “inadequate servicing” were, in fact, remanufacturing, not servicing.
A draft of the guidance was issued on June 24, 2021, after which several public comments were received and considered. The May 2024 guidance is a culmination of these efforts.
Highlights of the Guidance
The guidance provided updated definitions to distinguish between servicing and remanufacturing. Servicing is the “repair and/or preventative 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 original equipment manufacturer (OEM) and to meet its original intended use.”
In contrast, the guidance defines remanufacturing as 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.” Notably, the FDA also states that the distinction between servicing and remanufacturing is unrelated to a medical device’s classification as class I, II, or, III.
Even if a medical device company self-identifies as a servicer or remanufacturer, the FDA will evaluate the underlying activities performed on the device to determine whether they result in significant changes to the device’s intended use, safety, or performance. FDA defines a “significant change” as one that exceeds the OEM’s specifications, introduces new risks, or significantly modifies existing risks.
Instead of adhering to the OEM’s self-identified designation, the FDA provided six guiding principles to determine when underlying activities are remanufacturing:
- Assessing whether there is a change to the intended use.
- Determining whether there are significant changes, individually or cumulatively, to the device safety or performance.
- Weighing whether changes to the device require premarket notification.
- Measuring the effect of new or modified parts that deviate from the OEM’s components.
- Identifying new or modified risks that did not previously exist in the original device.
- Documenting in sufficient detail the rationale for whether an activity is servicing or remanufacturing.[1]
In a flowchart on page 11 of the guidance, the FDA asks four main questions:
- Does the activity performed by the medical device company affect a component that contacts body tissue?
- Does the activity change any dimensional or performance specifications?
- Is there a new or modified risk?
- Is there a significant change to device performance or safety specifications?
In addition to this general classification framework, the FDA believes the following types of activities, in general, involve changes that affect the legally marketed device’s performance or safety specifications and are likely to constitute remanufacturing:
- Changes to the device’s sterilization methods.
- Changes to the device’s reprocessing instructions.
- Changes to the device’s control mechanism, operating principle or energy type.
For maintenance activities involving physical components, the FDA would apply the framework. However, for changes involving software, many will likely be remanufacturing because of their effect on product architecture. On page 16 of the guidance, the FDA provides a limited list of software activities that are likely not remanufacturing, including running diagnostics and managing user accounts. Any other software activity is likely to be seen as remanufacturing,
The guidance could affect multiple stakeholders in the medical device industry. Regulatory requirements do not solely apply to OEMs but also to third-party servicers and independent service organizations. For example, on product labeling, manufacturers and remanufacturers must provide adequate servicing instructions.
Similar to manufacturers, remanufacturers must report adverse events and defects under the Medical Device Reporting regulations. All medical device companies should be aware of other premarket notifications, reports of corrections and removals, and quality systems. As a key distinction, remanufacturers must register as device manufacturers and maintain their own device listings independent of OEMs, while third parties only engaged in servicing and not remanufacturing do not.
Beginning on page 23 of the guidance’s Appendix, the FDA provides several examples (only some shown here) of various activities and whether they would be classified as servicing or remanufacturing:
| Servicing | Remanufacturing |
| The slide heater pads on an autostainer are worn out and are replaced with an OEM part. | The heating chamber of a tissue pretreatment water bath was updated by replacing the heating chamber, and the new one uses a different temperature range. |
| A stainless steel manual drill intended for use in the implantation of orthopedic devices is being reprocessed and reused for multiple procedures. It was sharpened for the first time because it is dull and difficult to use. | A device designed to run using Microsoft Windows is adjusted to allow the device to run using a Linux operating system. |
Observations
Remanufacturers should heed The Fixx’s reflection in its 1983 hit “Red Skies at Night” and take warning of the new guidance as they could be subject to the same oversight and enforcement as the original manufacturers. Companies should carefully document and evaluate whether the individual and cumulative effect of activities performed on devices is remanufacturing or servicing, utilizing the guidance’s principles, flowchart, and examples. Remember, as The Fixx noted in a 1982 hit, “one thing leads to another.”
The FDA appears most concerned with “unintentional remanufacturing” when third-party servicers lack adequate servicing instructions. Is this, as The Fixx sang in 1984, “the sign of fire”? The guidance should help clarify the rules for remanufacturers and servicers and, like The Fixx, answer, “Are we ourselves?”
Alan Minsk is a partner at Arnall Golden Gregory LLP. He leads the firm’s Food & Drug practice and co-chairs the Life Sciences industry team. He can be contacted at [email protected].
* Minsk would like to thank AGG summer associate Aditya Krishnaswamy for his contributions to this article.
[1] FDA allows companies to provide their own well-documented rationale, which should contain sufficient detail to explain why an activity does or does not constitute a significant change.
