Following a decision against extending regulatory requirements to third-party device servicers, the US Food and Drug Administration (FDA) is seeking feedback to inform upcoming guidance on the distinction between servicing and remanufacturing.
The agency laid out its initial thoughts about certain concepts, including guiding principles, a software-based complementary approach and labeling considerations, in a new white paper issued on Tuesday to guide the discussions of a two-day public workshop set for December.
The white paper also provides a flowchart that “aims to help distinguish between servicing and remanufacturing by addressing activities performed on a legally marketed device,” FDA said
. It is intended to be used in conjunction with the text in Section 5 of the white paper and applied to “each action performed on the device as well as the actions in aggregate.”
The flowchart provides examples of the activities that would fall outside of the scope of what constitutes device servicing for FDA purposes. These include changes to sterilization methods, reprocessing instructions and the control mechanism, operating principles or energy type as well as significant changes to intended use, such as when a device becomes reusable.
“Stakeholders should consider whether they agree with this list [of remanufacturing activities] or whether any activities should be added or removed to represent examples of changes that do not constitute servicing,” FDA said. A docket
will remain open until 21 January 2019 for input.
Feedback on the white paper, particularly the proposed draft flowchart, and the workshop discussions will be used to develop draft guidance as FDA’s Center for Devices and Radiological Health (CDRH) committed to in its March report
to Congress on the issue.
The report revealed CDRH’s long-awaited decision to not impose additional requirements on device servicers, citing a lack of data to support claims of poor-quality servicing. The decision was met with mixed reactions as some trade organizations lauded CDRH for wading into the device servicing issue while others raised concerns over a lack of regulatory oversight.
The five guiding principles in the white paper include “servicing does not significantly change the safety or performance specifications of a device,” “evaluate whether any changes to a device require a new 510(k),” and a risk-based approach to assessments on device servicing vs. remanufacturing, among others. FDA seeks input on whether firms agree with the principles.
Input is also sought on a list of activities performed on software that would be considered servicing, the servicing information that should be made available to patients via device labeling and how the questions in Section 8 are considered for each of the example scenarios that follow, ranging from infusion pumps and ultrasound devices to software as a medical device.