MITA Seeks Third-Party Servicer Buy-In For Quality Standards Pending FDA Report
The Medical Imaging Technology Alliance has pulled together a consensus body of original equipment manufacturers, third-party servicers and others to create voluntary quality management system standards for servicing advanced imaging and other medtech equipment, while stakeholders look ahead to an FDA third-party servicing report due in May.
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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.
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."
House Energy and Commerce Committee members added a slate of industry-favored device amendments into the FDA Reauthorization Act before sending the bill to the chamber floor, including reforms targeting device accessories, medical imaging and post-market surveillance.