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QUOTED. 25 November 2020. Ricki Chase.

Executive Summary

The US FDA’s decision to ask on device adverse event reports whether the device involved had been serviced by a third party could help the agency as well as device makers, says Ricki Chase, compliance practice director at Lachman Consultant Services.

“The FDA is trying to solve a lot of problems in a question that’s basically trying to get at who the heck is servicing the equipment. I think the agency is trying to get its arms around the diversity that’s happened in the marketplace with these servicers, and I think it’s trying to get its arms around responsibility, and I think it’s trying to get its arms around where the influence may be coming from in any particular reportable event.” – Ricki Chase, compliance practice director, Lachman Consultant Services

 

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