What if no medically established means for diagnosing the disease or condition exists?
If there is no medically established diagnostic product or procedure and clinical investigators use the results from the investigational study to decide on treatment, FDA would not consider the study exempt from IDE requirements under 21 CFR 812.2. The sponsor would need to obtain FDA approval of an IDE if the results are used in diagnosis without confirmation (e.g., to assist in determining treatment) (21 CFR 812.1, 812.2) and if a significant risk device is involved. • Can an investigational IVD device be used outside of the study protocol, in an emergency situation? Yes. (See also Chapter III, “Expanded Access to Unapproved Devices,” of the guidance document “IDE Policies and Procedures.”)3 A physician may use an investigational IVD device in an emergency situation if: • the patient has a serious disease or condition; • no generally accepted alternative diagnostic device or treatment for the condition is available; and • there is no time to use existing procedures to get FDA approva
