/ FORM:Device Compassionate Use (Pre-Use) Review Request /
Document No.: / Edition No.: / Effective Date: / Page:
HRP-222 / 001 / 07 Feb 2017 / Page 1 of 2
This form is designed for those pursuing prospective IRB review for compassionate use of a device as outlined in the FDA guidance Emergency Use and Compassionate Use of Unapproved Devices.
You must submit a typed version of this form to prevent errors and delays due to legibility problems.
Blank & incomplete answers will result in delayed reviews
If you have questions about the use of this form, please call 1-800-562-4789 or email
Physician name: / Sponsor Protocol #:
Company/Institution:
Name of device:
Planned date(s) of use:
Provide the patient’s history sufficient to justify that:
  • The patient has a serious condition
  • The condition needs immediate treatment, diagnosis, or monitoring
  • No generally acceptable alternative for the condition exists
  • The patient does not meet inclusion criteria for an IDE study
  • The probable risk to the patient from the device is not greater than the probable risk from the disease

Describe the treating physician’s schedule for monitoring the patient, taking into consideration the investigational nature of the device and the specific needs of the patient:
Yes / No / In most cases the answers below must be “Yes” to proceed with the use of the device:
Does the device have an IDE?
Has the sponsor authorized this use of the device?
Has FDA concurred with this use of the device?
Confirm that the treating physician will:
  • Document in the medical record that:
  • The patient has a serious condition
  • The condition needs immediate treatment, diagnosis, or monitoring
  • No generally acceptable alternative for the condition exists
  • The patient does not meet inclusion criteria for an IDE study
  • The probable risk to the patient from the device is not greater than the probable risk from the disease
  • Have a physician who is not participating in the use of the device document in the medical record that:
  • The patient has a serious condition
  • The condition needs immediate treatment, diagnosis, or monitoring
  • No generally acceptable alternative for the condition exists
  • The patient does not meet inclusion criteria for an IDE study
  • The probable risk to the patient from the device is not greater than the probable risk from the disease
  • Obtain clearance from the institution where the device will be used as specified by their policies
  • Not proceed with the use until there is written concurrence of an IRB chair
  • Obtain informed consent from the patient or legal representative
I confirm
By submitting this form, I confirm that:
  • I am the treating physician or treating physician’s designee authorized to submit on behalf of the PI.
  • The treating physician has full awareness of the information within this form.
  • The information within this form is accurate and complete.
I confirm
Name of person completing form:
Name: / Date:
Title:
Company:
Phone: / Email: