The FDA is seeking feedback from devicemakers to help craft guidance on the difference between servicing and remanufacturing devices.
The agency released a white paper to guide discussion at a Dec. 10-11 public workshop that will discuss potential criteria on which the FDA might base its determinations. The white paper contains the agency’s initial thoughts about guiding principles and considerations for software and labeling.
The FDA wants to address previous industry comments that suggested inadequate servicing of devices related to adverse events and deaths. The agency believes the problems were a result of remanufacturing rather than servicing.