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QUOTED. May 4, 2018. Sean Boyd.

Executive Summary

As the global Medical Device Single Audit Program gets off the ground, US FDA says it sees additional ways MDSAP audits could support its regulatory mission. See what FDA official Sean Boyd said about it here.

"Could we apply them in situations other than for routine surveillance inspections? Could we think about accepting an MDSAP audit report for a pre-approval inspection?" – Sean Boyd, deputy director for regulatory affairs, Office of Compliance, FDA's Center for Devices and Radiological Health

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