Manufacturers Share Doubts About FDA’s ISO 13485 Audit Report Program
This article was originally published in The Gray Sheet
A voluntary new FDA program aims to relieve the inspectional load on manufacturers and the agency. But some device companies are skeptical that anyone will participate.
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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.