MRA third party guidance
This article was originally published in The Gray Sheet
Executive Summary
European conformity assessment bodies reviewing a 510(k) submission or conducting a quality system evaluation in accordance with the U.S./EU mutual recognition agreement may not use personnel who were employed within the last twelve months by the sponsor or inspected firm, FDA says in a Jan. 6 updated version of its guidance document on third-party programs under the MRA. The extra condition regarding the prevention of conflicts of interest is one of the few changes to the document
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