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 approval for the emergency use. FDA recommends that the physician make the determination that the patient’s circumstances meet the above criteria, to assess the potential for benefit from the use of the unapproved device, and to have substantial reason to believe that benefits will exist. In the event that a device is used in circumstances meeting the criteria listed above, the physician should follow as many of the patient protection procedures listed below as possible. These include obtaining: • Informed consent from the patient or a legally authorized representative; • Clea
Related Questions
- Can an unapproved or uncleared investigational IVD device ever be used for non-emergency treatment of patients who do not meet the inclusion criteria of an investigational study?
- What information should the protocol include to ensure that the investigational IVD study will be scientifically sound?
- Can an investigational IVD device be used outside of the study protocol, in an emergency situation?
