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Shuren's CDRH Sets Ambitious 2010 Agenda: 510(k), PMA Changes Planned

This article was originally published in The Gray Sheet

Executive Summary

CDRH launched an ambitious 2010 agenda Jan. 20 that includes changes to the 510(k) and PMA pre-market programs by this fall, harmonized international inspection activities by 2011 and unique device identifiers by 2013
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