On 24 June 2021, the U.S. Food and Drug Administration (FDA) issued a draft guidance on Remanufacturing of Medical Devices, which “is intended to help clarify whether activities performed on devices are likely ‘remanufacturing.’”
This is another piece of the FDA’s journey to clarify various activities undertaken—and their associated regulatory implications—on reusable devices over their useful life. In this draft, the FDA draws distinctions between “remanufacturing” and “servicing.”
Remanufacturing vs. Servicing
“Remanufacturing” has significant regulatory implications for the remanufactured device and the organization undertaking that activity (if they have significantly changed the device and it is likely a “new” device).
In contrast, servicing, by definition, “excludes [emphasis added] activities that significantly change the finished device’s safety or performance specifications, or intended use.” Therefore, servicing usually creates less regulatory burden on the servicing organization.
Implications for UDI and DIs
Though the draft guidance does not address Unique Device Identification (UDI) specifically, I think there are some interesting implications worth discussing.
We often struggle to differentiate the UDI implications of remanufacturing, refurbishing, servicing, and repair, and have found that there are two important distinctions that affect UDI. The first is whether the activity (significantly) changes the device, such that a new device identifier (DI) is required (and whose DI should be used). The second is whether the activity constitutes a new act of commercial distribution such that a UDI is required for a device that may not previously have had one. (That is, the device was initially distributed prior to the applicable UDI class compliance date.)
We also need to remember that a new DI is required whenever a “change results in a new version or model” (21 CFR 830.50). This new DI also has other implications for Quality Systems, labeling, and the Global Unique Device Identification Database (GUDID).
With respect to when a new UDI is required, we need to differentiate remanufacturing from both servicing and refurbishing. It seems clear that if a device has been subject to the FDA’s definition of remanufacturing (“processing, conditioning, renovating, repackaging, restoring, or any other act done to a finished device that significantly changes [emphasis added] the finished device’s performance or safety specifications, or intended use”), then it is a very likely a different (new) device and must be labeled (or more likely relabeled) with a DI that reflects both the organization (labeler) that remanufactured the device and the model/version of this “new” device.
In the draft guidance, the FDA provides a flowchart and other information to help you determine whether the activities performed are “likely remanufacturing.” Conversely, though not referenced in this draft guidance, in the 2016 Federal Register Notice on “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices” and the 2018 white paper on “Evaluating Whether Activities are Servicing or Remanufacturing,” the FDA provides a working definition of refurbishing, which is to “restore [a] device to a condition of safety and effectiveness that is comparable to when new [emphasis added].”
Based on these distinctions, we typically suggest a new DI for devices undergoing remanufacturing, but not for those undergoing refurbishing, as these devices have not significantly changed (they are, per the definition, the same as when the device was new). However, if the refurbished device is being (re-) introduced into commercial distribution (e.g., provided to a new customer), then the device must be UDI compliant. This does present some challenges if the organization refurbishing the device is not the Original Equipment Manufacturer (OEM). Regardless, it is critical to document both the processes and criteria for making these determinations and the specific results with respect to individual devices.
With respect to servicing, it is clear that, like refurbishing, these activities do NOT significantly change the device and therefore do not likely create a “new” device. However, for purposes of UDI application, we need to differentiate between servicing and repair (in the way that the FDA defines these terms).
By definition, repair is a “type of servicing that … returns the device to the current owner of the device [emphasis added].” Because of this, we have NOT considered the return of repaired devices to the existing owner to be a new act of commercial distribution. Conversely, servicing, which is not repair, typically involves a new act of commercial distribution (a device which is being “held or offered for sale”) because the device is being provided to a new customer.
Therefore, if the serviced device is not currently UDI complaint, it must be made UDI compliant before being distributed. Again, this may present some challenges if the organization servicing the device is not the OEM, and these processes and outputs should be well documented.
FDA’s View on Software
More interesting, however, is the FDA’s view on software. In the draft guidance, the FDA specifically distinguishes software changes from other activities and states that most software changes are likely remanufacturing “because of their impact on a product’s software architecture, software requirements specifications, unresolved anomalies, and other key characteristics.”
To help clarify, the FDA lists various software-related activities “that are likely not [emphasis added] remanufacturing because they generally do not significantly change the performance or safety specifications of the [software] device.” These include, but are not limited to:
- Installing cybersecurity updates that are authorized by the OEM
- Performing data backup and recovery operations
- Accessing diagnostic and repair information
Conversely, the FDA states that “other activities involving changes to software are likely to significantly [emphasis added] change a device’s performance or safety specifications, such that the activity is likely remanufacturing.”
As above, when a software change is considered remanufacturing, a new DI will likely be required. Previously, we had relied on the discussion of major (new DI) vs. minor (new Production Identifier [PI]) software changes from section 10.6 of the 2013 IMDRF UDI Guidance to steer our discussion of new DI requirements for software (which is very similar to the requirements in the European Union [EU] Medical Devices Regulation/In-vitro Diagnostics Regulation [MDR/IVDR]).
We will need to revise our UDI approach to software to incorporate the FDA’s new thinking.
How USDM Can Help
From design to post market, managing change to your medical device is critical. A seemingly small process deviation or change to a component can cause major problems such as product quality issues, patient safety, data loss, and possible regulatory actions or recalls. Our Medical Device division helps you bring your products to market faster, monitor your products in the field, and handle post-market surveillance while addressing a variety of regulatory challenges unique to the Medical Device industry.
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