On June 18th, FDA published a draft guidance document titled Remanufacturing of Medical Devices, which has been several years in the making. The draft guidance distinguishes between “remanufacturing” and “servicing” of devices. This distinction can be critical, due to the significantly increased regulatory requirements that apply to a device remanufacturer compared to a device servicer.
In 2016, FDA opened a docket seeking comments on “service, maintenance, refurbishment, and alteration of medical devices” by third parties (see our blog post here). Two years later, in 2018, FDA issued a Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices (see our blog post here). The 2018 report listed several planned actions by the Agency, one of which was to clarify the difference between servicing and remanufacturing. The new remanufacturing draft guidance appears to be the result of this action item in the 2018 servicing report.
A remanufacturer is defined in FDA’s Quality System Regulation (QSR) as “any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the device’s performance or safety specifications, or intended use.” 21 C.F.R. § 820.3(w). “Remanufacturing” is also included in the definition of “manufacturer” in the regulations. Id. § 820.3(o). Because a remanufacturer is defined as a type of manufacturer in the QSR, a remanufacturer must comply with all of the stringent regulatory requirements that apply to a device manufacturer including design controls, production and process controls, complaint handling, and more.
In contrast, a device servicer is not a device manufacturer and, therefore, need not comply with the QSR. “Service” is defined in the draft guidance as “repair and/or preventive or routine maintenance of one or more parts on a finished device, after distribution, for purposes of returning it to the safety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 use.” According to the draft guidance, servicing excludes activities that significantly change a finished device’s safety or performance specifications or intended use, which would instead fall within the definition of remanufacturing.
Both the 2018 servicing report and the draft guidance note that the majority of complaints and comments received by FDA on inadequate “servicing” that caused or contributed to adverse events or deaths were actually remanufacturing activities. The draft guidance includes a framework and decision-making flow chart that can be used to distinguish servicing from remanufacturing, and in turn, properly identify the regulatory requirements that apply to the activity.
The draft guidance begins with several “guiding principles” that FDA recommends applying in assessing whether an activity is remanufacturing or servicing:
- assessing whether there is a change to the intended use;
- determining whether the activities, individually or cumulatively, significantly change the safety or performance specifications of the finished device;
- evaluating whether any change to a device would otherwise require a new marketing submission (e.g., in accordance with FDA’s guidance on Deciding When to Submit a 510(k) for a Change to an Existing Device);
- assessing changes to dimensional and performance specifications, including to components, parts, or materials;
- employing a risk-based approach (e.g., in conformance with ISO 14971) to assess whether an activity is significantly changes performance or safety specifications and therefore should be considered remanufacturing; and
- adequately documenting decision-making to help justify decision-making in the event that an inspection is conducted by FDA or the entity’s rationale is otherwise requested by FDA.
FDA defines a “significant change to device performance or safety specifications,” which would be considered remanufacturing, to be a change 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.” The draft guidance identifies certain types of activities that FDA believes significantly change the legally marketed device’s performance or safety specifications: changes to the device’s sterilization methods; changes to the device’s reprocessing instructions; and changes to the device’s control mechanism, operating principle, or energy type.
The draft guidance includes a decision-making flowchart to assess whether a modification to a finished device would be considered remanufacturing. The flowchart is meant to be used only after an entity has determined that a modification to a device does not significantly change the intended use of a device, because a significant change to the intended use of a finished device would likely be considered remanufacturing. The flowchart includes questions on adding, removing, or changing a component, part, or material, and assessing whether there are any new or modified risks or significant changes to performance or safety specifications. If any modification to a finished device is a significant change to a device performance or safety specification, the modification is considered remanufacturing.
While the flowchart provides a helpful framework for assessing device modifications, it is very high-level and lacking in detail, so a close read of the illustrative examples and definitions provided in the draft guidance would be required to adequately assess whether a modification constitutes remanufacturing.
The draft guidance recommends that entities performing servicing activities document their decisions that an activity is not remanufacturing in internal memoranda. This documentation can be used to justify or explain an entity’s decision-making in the event of an FDA inspection or other request from the Agency. In an appendix to the draft guidance, FDA provides some helpful examples of the type of information that should be included in such an internal memo.
Now that there is more specific guidance from FDA on what distinguishes servicing from remanufacturing, though only a draft guidance, entities that routinely perform servicing activities should consider implementing a procedure to assess whether an activity significantly changes a device’s intended use or specifications such that it meets the definition of remanufacturing. Such a procedure could include the decision-making flowchart in FDA’s draft guidance and a template form for documentation of decision-making consistent with the examples in the draft guidance.
Interested parties have until August 23, 2021, to comment on the draft guidance.