Off-Label Use of HUD Report

SECTION 1.0: Submission Information & Instructions
1. Submission information: Please us this form to submit a report of off label use of a Humanitarian Use Device. To determine on/off label indications see Instructions for Use and/or original FDA HDE approval letter. Schulman IRB policy requires reports of off-label use of HUDs within 5 working days. If you report falls outside of this timeframe it will be necessary to complete a non-compliance form.
2. Submission instructions: Submit to Schulman IRB via Secure eSubmission, email to or fax to (866) 596-1535.
SECTION 2.0: General Information
1. HUD device common name: / 2. HUD number:
3. IRB number:
SECTION 3.0 Site Contact Information
1. Clinician/User and Site Information:
Clinician Name: / Site Name:
Email: / Address:
Phone: / City: / State:
Fax: / Postal Code:
2. Site Contact Information for IRB Related Issues:
Name: / Title:
Phone: / Fax: / Email:
SECTION 4.0: Regulatory Criteria
1. Regulatory requirements and guidance regarding off-label use of HUDs include:
a. / Physician should obtain informed consent.
b. / Ensure reasonable patient protection measures are followed, such as devising schedules to monitor the patient.
c. / Submit a follow-up report on the patient’s condition to the HDE holder.
d. / Check for any institutional policy regarding off-label use of HUD before such use.
e. / Submit any MDR reports if device malfunctions or if such off-label use causes or contributes to the death or serious injury of a patient.
SECTION 5.0: Documentation
1. Please describe the off-label use (indication, circumstances, procedure, clinical outcomes, current status).
2. Please provide copies of documents used or generated to meet the requirements above (Section 4.1) including:
a. / Redacted copy of informed consent form.
b. / Copy of follow-up report on the patient’s condition to the HDE holder.
c. / Copy of any MDR reports generated in this event of use.
SECTION 6.0: Investigator Certification & Signature
I certify that I have thoroughly reviewed the information provided on this form and that the information provided is true and accurate.
Clinician/User Signature Required / Signature Date (mm/dd/yyyy)
Version: May 5, 2017 / © 2017 Copyright SCHULMAN / Page 1 of 1