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Home » CDRH Adopts Risk-Based Approach To Device Trial Monitoring
CDRH Adopts Risk-Based Approach To Device Trial Monitoring
August 8, 2007
The FDA is trying to be proactive in regulating device clinical trials through bioresearch monitoring (BiMo) audits, Tim Ulatowski, Director of Compliance for the FDA’s Center for Devices and Radiological Health (CDRH), said.