Q1: According to the description in the FDA IDE Approval Process, in what circumstances can a clinical investigator submit an EFS/IDE for the Significant Risk Device (or to say, to be a sponsor-investigator)？
Q2: Would it be acceptable to use the sponsor-investigator studies data to support a marketing application (like PMA)? Thanks for your attention first.
FDA IDE Approval Process: The sponsor of the clinical trial is responsible for submitting the IDE application to the FDA (§812.40) and obtaining Institutional Review Board (IRB) approval before the study can begin. Foreign companies wanting to conduct a clinical study in the U.S. MUST have a U.S. sponsor (§812.18). Under certain circumstances, the clinical investigator may wish to submit an IDE and would, therefore, also act as the sponsor of the study.
Q2: Would it be acceptable to use the sponsor-investigator studies data to support a marketing application (like PMA)? Thanks for your attention first.
FDA IDE Approval Process: The sponsor of the clinical trial is responsible for submitting the IDE application to the FDA (§812.40) and obtaining Institutional Review Board (IRB) approval before the study can begin. Foreign companies wanting to conduct a clinical study in the U.S. MUST have a U.S. sponsor (§812.18). Under certain circumstances, the clinical investigator may wish to submit an IDE and would, therefore, also act as the sponsor of the study.
