The FDA must be contacted prior to the Emergency Use of an investigational drug or biologic product. FDA contacts for obtaining an Emergency IND for the use of an investigational drug or biologic are available at the Emergency IND Information Sheet.
For Emergency Use of a medical device, prior FDA approval is not necessary so long as the following criteria are satisfied:
- The patient has a life-threatening condition that needs immediate treatment;
- No generally acceptable alternative treatment for the condition exists; and
- Because of the immediate need to use the device, there is no time to use existing procedures to obtain FDA approval for the use.
The FDA expects the physician to 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.
If the physician wants an opinion from FDA regarding whether or not the case meets criteria or emergency use, FDA Expanded Access Contact Information is available for both during and after business hours. Also, see this FDA website link: Expanded Access for Use of an Investigational Medical Device.