FDA’s ISO Audit Program Chugs Along; May Be Absorbed By IMDRF Single-Audit Initiative
This article was originally published in The Silver Sheet
Executive Summary
Thirty manufacturers have used FDA’s ISO 13485 voluntary audit program since the two-year pilot began last June, freeing up scarce agency inspectional resources to be used elsewhere. However, it will likely be eventually absorbed by a pilot Medical Device Single Audit Program currently under development by the International Medical Device Regulators Forum.
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