|Footnotes for this article are available at the end of this page.
The Food and Drug Administration issued new draft guidance titled, “Remanufacturing of Medical Devices,” on June 17, 2021, with the goal of clarifying whether activities performed on medical devices are considered remanufacturing.1 As noted by William Maisel, M.D., Director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health, “[i]t is important for industry personnel, such as original equipment manufacturers, servicers and remanufacturers, to have a clear understanding of activities that are considered remanufacturing so that they can apply appropriate statutory and regulatory requirements which exist to keep the American public safe.”2
The draft guidance document is a continuation of the work that FDA has been doing since 2016 when the agency opened a docket for public comment and held a public workshop to gain additional perspectives on the distinction between “servicing” and “remanufacturing.” In 2018, FDA issued a report on the “Quality, Safety, and Effectiveness of Servicing of Medical Devices,”3 discussing the comments, complaints, and adverse event reports alleging inadequate servicing received by the agency. The report concluded that “a majority of the comments, complaints, and adverse events reports received by the Agency that referred to inadequate “servicing” causing or contributing to adverse events and deaths actually pertained to ‘remanufacturing.’”4 Thus, it is important to understand the difference between “remanufacturing” and “servicing” of a medical device.
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specifications, or intended use.5 There is no regulatory definition for the term “servicing,” but it is defined by the draft guidance as the “repair and/or preventive or routine maintenance of one or more parts in a finished device, after distribution, for purposes of returning it to the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 [original equipment manufacturer (OEM) and to meet its original intended use.”6 Therefore, an entity engaged in remanufacturing must comply with all of the regulatory requirements set forth in FDA’s Quality System Regulation.
In determining whether a company is a “servicer,” or a “remanufacturer,” FDA focuses on the types of activities an entity performs on a particular device. Thus, the same entity may be both a servicer and a remanufacturer on one or multiple medical devices.7
The draft guidance sets forth six (6) guiding principles to help determine whether the activities performed by an entity are considered 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. FDA notes that it considers a “change” to also include activities that improve the device. Multiple changes, when considered together, may also significantly change the performance or safety specifications of the device and, as such, should be evaluated.
- Evaluate whether any changes to a device require a new marking submission in accordance with FDA’s guidance titled “Deciding When to Submit a 510(k) for a Change to an Existing Device.”8
- Assess component/part/material dimensional and performance specifications.
- Employ a risk-based approach to determine whether an activity significantly changes performance or safety specifications and should be considered manufacturing.
- Adequately document decision-making in order to help justify the firm’s decision-making in the event of an FDA inspection. Specifically, the documentation should specify why the activities performed on the device do or do not significantly change the performance or safety specifications, or intended use of the legally marketed device. FDA includes examples of such documentation in Appendix B of the draft guidance.
For purposes of the guidance, FDA considers a significant change to device performance or safety specifications to be one that, “based on verification and validation testing and/or a risk-based assessment, results in a finished device that is outside the OEM’s performance or safety specifications or introduces new risks or significantly modifies existing risks.”9 The draft guidance also includes a flowchart to help entities determine if an activity is likely manufacturing.10
Changes Involving Software
FDA provides some considerations for changes involving software in the draft guidance. Specifically, FDA notes, “software changes are likely remanufacturing because of their impact on a product’s software architecture, software requirements specifications, anomalies, and other key characteristics.”11 The draft guidance provides the following examples of activities performed on software that are likely not manufacturing because they generally do not significantly change the performance or safety specifications of the device:12
- Activities performed on behalf of or otherwise explicitly authorized by the OEM that return the legally marketed device to its performance and safety specifications, and intended use;
- Implementing OEM provided updates and upgrades;
- Running software-based hardware diagnostics;
- Assessing for viruses, malware, and other cybersecurity-related issues;
- Reinstalling OEM software to restore original performance and safety specifications;
- Reverting software to a previous configuration;
- Installing cybersecurity updates that are authorized by the OEM;
- Turning on or off connectivity features (e.g., Wi-Fi and Bluetooth connections) consistent with OEM intended use;
- Performing data backup and recovery operations;
- Assessing software inventory;
- Collecting system logs;
- Managing user accounts; and
- Accessing diagnostic and repair information.
The draft guidance provides some general labeling guidelines for OEMs of reusable devices that must routinely undergo both preventative maintenance and repair. FDA encourages OEMs to provide the following information, as applicable:
- A description of the key performance and safety specifications;
- Critical technical or functional specifications, including:
- Physical dimensions;
- Electrical characteristics, including batteries (e.g., chemistry, amperage, voltage, rechargeability), internal fuses, and power supply (e.g., voltage, amperage, frequency); and
- Device-specific performance specifications (e.g., flow rate accuracy or range, humidity, temperature, wavelength.)
- The recommended maintenance activities and schedule;
- Recommended routine testing and acceptance criteria to confirm that the device remains within its performance and safety specifications;
- A description of error codes, alerts, and alarm features on the device;
- Precautions and warnings relevant to servicing the device; and
- Version number and release date of software.
- The draft guidance provides much-needed clarification on what constitutes remanufacturing vs. servicing of medical devices. While only in draft, entities involved in remanufacturing and/or servicing devices should consider using the FDA’s guidance to develop procedures to determine whether an activity significantly changes a device’s intended use or specifications.
- As we often remind companies, we recommend documenting every decision made as it relates to the manufacturing of a medical device. FDA provides some useful examples of the type of documentation that the agency will be looking for during an inspection. Based on the guidance, it is clear that FDA will be paying close attention to the activities that an entity is performing on a device to determine whether it needs to meet higher regulatory standards.
- Entities making changes to software must ensure that they are properly documenting their decisions as to whether the change is considered to be remanufacturing. As noted by the agency, only a few activities performed on software are not likely to be remanufacturing. Thus, the chances of FDA taking issue with a software change that is not properly documented is increased.
 Available at https://www.fda.gov/media/150141/download. FDA also issued an accompanying White Paper titled, Evaluating Whether Activities are Servicing or Remanufacturing, available at https://www.fda.gov/media/117238/download.
 See FDA in Brief: FDA Issues Draft Guidance on Remanufacturing and Discussion Paper Seeking Feedback on Cybersecurity Servicing of Medical Devices, available at https://www.fda.gov/news-events/press-announcements/fda-brief-fda-issues-draft-guidance-remanufacturing-and-discussion-paper-seeking-feedback.
 Available at https://www.fda.gov/media/113431/download.
 See Draft Guidance at 2.
 See 21 C.F.R. § 830.3(w).
 See Draft Guidance at 3.
 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device.
 Draft guidance at 8.
 See Draft guidance at 11.
 Id. at 15.
 Id. at 16.