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CDRH Strategic Plan Calls For Database To Identify 'Compliance Targets'

This article was originally published in The Silver Sheet

Executive Summary

A DATABASE THAT WILL HELP FDA PINPOINT 'COMPLIANCE TARGETS' is among the action items included in CDRH's 2010 Compliance Strategic Plan. "We want to use data from databases that are maintained within the agency and possibly data outside the agency to help us develop a risk profile of particular firms," says Steve Silverman, senior advisor to CDRH Director Jeffrey Shuren. The database could enhance FDA's risk-based inspection approach, which allows compliance officers to decide which types of devices and facilities to focus on each year based on the likelihood of manufacturing or safety problems. The strategic plan also calls for a tighter relationship between CDRH and FDA's Office of Regulatory Affairs, as well as mechanisms to deliver warning letters to manufacturers faster





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