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An investigator may determine whether potential participants would be interested in participating in an investigation, but shall not request the written informed consent of any participant to participate, and shall not allow any participant to participate before obtaining IRB and FDA approval. [21 CFR 812.110].
The investigator is responsible for providing a letter or an e-mail from the FDA giving the IDE number, if applicable, as assigned by the FDA. The sponsor-investigator is responsible for:
- Ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable FDA regulations.
- Protecting the rights, safety, and welfare of subjects under the investigator’s care
- Ensuring the control of devices under investigation.