Auditing device clinical studies for US requirements.
Medical device manufacturers conducting clinical studies outside the United States (US) to support US regulatory submissions should be prepared to show that these studies are conducted in a manner that will be acceptable to the Food and Drug Administration. This article discusses the audits that can be conducted to assess this acceptability.
Donawa
Maria
M
Dona Consulting, Rome, Italy. medonawa@donawa.com
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D019983:Guideline Adherence / Q000331:legislation & jurisprudence* / Q000592:standards; D008485:Medical Audit / Q000331:legislation & jurisprudence* / Q000592:standards; D014481:United States