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…