The Fixx: FDA Clarifies Distinctions Between Medical Device Servicing and Remanufacturing

The 1980s British rock band, The Fixx, comes to mind when one reads the Food and Drug Administration’s recently issued “Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff” (the “Guidance”).¹

The Guidance provides a framework to classify activities performed by entities as “servicing” or “remanufacturing” of reusable medical devices. It is a non-legally binding guidance document that offers FDA’s current thinking on the subject.

Activities that constitute significant changes are remanufacturing, not servicing. Entities engaged in remanufacturing are subject to the same regulatory obligations as the original manufacturer, including marketing submissions and reporting requirements.

This Bulletin will highlight key points of the Guidance and offer AGG’s observations.

Background

• 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, 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 provides updated definitions to distinguish 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.”
  • “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.”
• 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,” FDA will evaluate the underlying activities performed on the device to determine whether there are significant changes to a 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.
• FDA provides six guiding principles to determine when underlying activities are remanufacturing, such as:
  1. Assessing whether there is a change to the intended use.
  2. Determining whether there are significant changes, individually or cumulatively, to the device safety or performance.
  3. Weighing whether changes to the device require premarket notification.
  4. Measuring the effect of new or modified parts that deviate from the OEM’s components.
  5. Identifying new or modified risks that did not previously exist in the original device.
  6. Documenting, in sufficient detail, the rationale for whether an activity is servicing or remanufacturing.²
• In a useful flowchart (found on page 11), FDA asks four main questions:
  1. Does the activity performed by the medical device company affect a component that contacts body tissue?
  2. Does the activity change any dimensional or performance specifications?
  3. Is there a new or modified risk?
  4. Is there a significant change to device performance or safety specifications?
• FDA believes certain activities per se result in significant changes that are likely to constitute remanufacturing:
  1. Changes to the device’s sterilization methods.
  2. Changes to the device’s reprocessing instructions.
  3. Changes to the device’s control mechanism, operating principle, or energy type.
• Many software changes are likely remanufacturing because of their effect on product architecture. FDA provides a limited list of software activities (found on page 16) that are likely not remanufacturing (any other software activity is likely to be seen as remanufacturing), including running diagnostics and managing user accounts.
• The Guidance notes that medical device regulatory requirements do not solely apply to OEMs, but also third-party servicers and Independent Service Organizations (“ISOs”).
  • In 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.
  • Remanufacturers must register as device manufacturers and maintain their own device listings independent of OEMs, while third parties only engaged in servicing, not remanufacturing, do not.
• In the Appendix (found on page 23), FDA provides several examples (only some shown here) to show how it would classify various activities as servicing or remanufacturing:
  • Servicing
    1. The slide heater pads on an autostainer are worn out and are replaced with an OEM part.
    2. A stainless-steel manual drill is intended to be used in the implantation of orthopedic devices. The drill is intended to be reprocessed and reused for multiple procedures. The drill was sharpened for the first time because it is dull and difficult to use.
  • Remanufacturing
    1. A tissue pre-treatment water bath was updated by replacing the heating chamber with one that has a different temperature range.
    2. A device designed to run the Microsoft Windows operating system (“OS”) is adjusted to allow the device to run using a Linux OS.

AGG Observations

• Remanufacturers should take note of the new Guidance, as they could be subject to the same oversight and enforcement as the manufacturers . . . be aware of “Red Skies at Night” (A 1983 hit by The Fixx).
• Companies should carefully document and evaluate whether the individual and cumulative effect of activities performed on devices are remanufacturing or servicing, utilizing the Guidance’s principles, flowchart, and examples. Remember, “One Thing Leads to Another” (1982 The Fixx single).
• FDA appears most concerned with “unintentional remanufacturing” when third-party servicers lack adequate servicing instructions. Is this “The Sign of Fire?” (1984 The Fixx single).
• The Guidance should help clarify the rules for remanufacturers and servicers, and answer “Are We Ourselves?” (1983 The Fixx single).

* The author would like to thank AGG summer associate Aditya Krishnaswamy for his contributions to this Bulletin.

[1] https://www.fda.gov/media/150141/download.

[2] 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.