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.
