Recent eMDR Change By FDA Asks Adverse Event Reporters About Third-Party Servicers
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.
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The US agency has completed planned modifications to its electronic Medical Device Reporting system – and added an extra field for MDR exemption numbers.
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."
King & Spalding partner Kyle Sampson tells Medtech Insight that a joint HHS/FDA notice that could exempt a plethora of medical devices from premarket review falls under a recent regulatory freeze from the Biden administration.