The FDA wants to know more about the challenges third-party entities face in maintaining or restoring devices to their original or current specifications.
To that end, the agency is asking industry for help in defining several terms related to refurbishing medical devices in a March 4 Federal Register notice. In addition, the FDA is seeking comments relating to:
The request for comments comes in the wake of stakeholders expressing concerns that some third-party entities may use unqualified personnel to perform service, maintenance, refurbishment, and device alterations on their equipment and that the work performed may not be adequately documented, the FDA says.
“Possible public health issues arising from these activities include ineffective recalls, disabled device safety features, and improper or unexpected device operation,” the agency says.
In addition, original equipment manufacturers have requested clarification on their duties if one of their devices has been serviced by a third party.
The agency says it intends to hold a public meeting later this year with stakeholders, and the comments obtained will help frame those discussions.