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Products > Health Care Compliance Association > HCCA’s 2006 RESEARCH Compliance Conference
Clinical Trials and the FDA—What You Really Need to Know

Doreen Kezer, Branch Chief, FDA / Office of Compliance

  • What is a medical device and why is compliancenecessary in device research?
  • CDRH BIMO Inspection Program overview
  • What should you do when a FDA Inspector shows up at your site?

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