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;
• Clearance from the institution as specified by their policies;
• Concurrence of the IRB chairperson;
• An assessment from a physician who is not participating in the study; and
• Authorization from the IDE sponsor, if an approved IDE exists for the device;
• Authorization from the device company, if no IDE exists.
Although prior FDA approval for emergency use of the investigational device is
not required, 21 U.S.C. § 360bbb(a), if an IDE exists, the use shall be reported to
FDA in a supplemental IDE by the IDE sponsor within 5 working days from the
time the sponsor learns of the use (21 CFR 812.35(a)(2)). The IDE supplement
should contain a summary of the conditions constituting the emergency, patient
outcome information, and the patient protection measures that were followed. If
no IDE exists, the physician should follow the above procedures and report the
emergency use to the sponsor and to CDRH or CBER, as appropriate.
