• For drugs or biologics, clinicians MUST contact the FDA prior to use of the drug or biologic. Step-by-step instructions for this process are here: https://www.fda.gov/news-events/expanded-access/expanded-access-how-submit-request-forms#AccessPhysEmerg.
  • For devices, clinicians are NOT required to contact the FDA prior to use of the device IF all the criteria for emergency use of a device are met. The FDA still advises that the clinician follow as many patient protection measures as possible when emergency use of a device occurs. These include obtaining:
    • Informed consent from the patient or a legal representative;
    • Clearance from the institution as specified by their policies;
    • Concurrence of the Institutional Review Board (IRB) chairperson or their designee;
    • An independent assessment from an uninvolved physician; and
    • Authorization from the device manufacturer.

To contact the FDA for approval of or guidance regarding a potential emergency use, please see the contact information found at the bottom of this page: https://www.fda.gov/news-events/public-health-focus/expanded-access.