An investigator conducting a study of a medical device under an ide is required to complete and sign

An investigator conducting a study of a medical device under an ide is required to complete and sign an investigator's agreement. It is a statement of the investigator's commitment to conduct the investigation in accordance with the agreement, the investigational plan, the IDE and other applicable FDA regulations, etc., it also supervise all testing of the device involving human subjects, and ensure that the requirements for obtaining informed consent are met.