No New Regulations Needed For Third-Party Servicers Of Devices, FDA Says
There is “not sufficient evidence” of a widespread public health concern relating to servicing of devices, including by third-parties, according to an FDA report; the agency sees no immediate needs to issue new regulatory requirements for the third-party servicers. The agency also intends to issue guidance to help clarify the difference between “servicing” and “remanufacturing."
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The addition of the question “Was this device serviced by a third party servicer?” to adverse event reports filed through the US FDA’s electronic Medical Device Reporting system could prove helpful for the agency and device makers, experts tell Medtech Insight. Industry has long complained about poor work performed by servicers – and loudly groused that they’re not regulated.
US FDA’s device center in concert with third-party servicers and original equipment manufacturers are working toward consensus on how to differentiate medtech "servicing" from "remanufacturing" activities. Progress was made at a recent workshop in laying out ways that better training and more data sharing will help.
In an interview with Medtech Insight, Bayer executive Dennis Durmis described some near-misses to patient safety involving shoddy repairs to his firm's devices. The incidents convinced him that Congress needs to pass legislation requiring all third-party servicers to register with US FDA and report adverse events to the agency.