224 - Project Revision/Amendment Form

Humanitarian Use Device

Progress Report

Florida Hospital Tampa Bay Division IRB

Continuing Review / Final Report
Full Board Continuing Review Instructions: / Expedited Continuing Review Instructions:
Submission deadline: Due on the 1st of the month for review on the 3rd Tuesday.
Submissions should be provided to the IRB as follows:
1) Via electronic format; or,
2) 17 collated paper copies / Guidance for HDE Holders recommends that Continuing Review of Humanitarian Use Devices be conducted by Expedited Review.
Section 47:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm110194.htm
Continuing Review Application: The form must be filled out completely, and signed. Please note that blanks and/or insufficient information may result in a delay of your review/approval.
Contact Information:
Today's Date: / Date of Initial Review: / Date of Last Continuing Review:
Type of Submission: / Continuing Review / Final Report – Termination requested
Type of Review Requested: / Full Review / Expedited Review
Humanitarian Use Device (HUD) Exemption #:
Device Sponsor:
Physician Approved for use:
Primary Contact: / E-mail:
Telephone: / Fax:
Status of Device Renewal:
If no longer seeking approval for continued use of the device, select “Final Report - Termination Requested”. The form must be completely filled out, including available safety information and applicable plans for research and/or commercial development.
Requesting Renewal / Final Report - Termination Requested
Summary of Device Usage Since Last Continuing Review:
No devices have been implanted since the last continuing review
Site of device usage: / Number of devices used per site:
Florida Hospital Tampa
Florida Hospital Pepin Heart Institute
Florida Hospital Carrollwood
Florida Hospital Zephyrhills
Florida Hospital Connerton (LTAC)
Florida Hospital North Pinellas
Total Device Usage
Summary of Product Information and Indications for Use Since Last Continuing Review:
Any revisions to the indications for use? Yes No
If yes, please describe new indications:
Was the device used outside its approved indications for use? Yes No
If yes, describe the use and justification for off-label use:
Was the IRB notified of the off-label use: Yes No
If no, please provide a brief summary of the reason the IRB was not notified:
Summary of Informed Consent Since Last Continuing Review:
Did the IRB require use of an Informed Consent form? Yes No
*If yes, please select the applicable informed consent status
Informed Consent Form (no change) / Current Use consent form version -
New Revised Informed Consent Form / New consent form version -
If Informed Consent was waived by the IRB, was the manufacturer patient information provided to the patient(s) prior to use of the HUD, with appropriate review and explanation? Yes No
If no, please provide an explanation of the omission:
Summary of New and/or Revised Product Information Since Last Continuing Review:
*Include new and/or revised material
FDA Status Change / Describe:
Manufacturer Product Labeling / Describe:
Clinical Brochure / Describe:
Manufacturer Provided Patient Information / Describe:
Safety and/or Benefit Information / Describe:
Product Information / Describe:
Publications / Describe:
Periodic Reports / Describe:
Other / Describe:
Comments:

IRB HUD Continuing Review 05-02-12

Summary of Adverse Events Since Last Continuing Review[i]:
Number of adverse events (at any site) requiring submission to the IRB:
Florida Hospital Tampa
Florida Hospital Pepin Heart Institute
Florida Hospital Carrollwood
Florida Hospital Zephyrhills
Florida Hospital Connerton (LTAC)
Florida Hospital North Pinellas
Any unanticipated problems involving risks to patients?
If yes, please explain: / Yes* No
Have any patients or others complained about the device?
If yes, please summarize (include relevant documents): / Yes* No
Have any obvious benefits occurred for patients receiving the device?
If yes, please summarize (include relevant documents): / Yes* No
Have any risks or potential benefits for this device changed?
If yes, please summarize (include relevant documents): / Yes* No

______

Signature of Principal Physician Approved for Use Date

IRB HUD Continuing Review 05-02-12

[i]

END NOTES

Serious Adverse Event Reporting
Events that occur at Florida Hospital Tampa Bay Division must be reported within 10 working days after the event is known to the investigator, or within 48 hours if the event involves a death.
Definition:
A Serious Adverse Event (SAE) includes death, life threatening events, hospitalization or prolongation of hospitalization, disability or incapacitation, overdose, congenital anomalies and any other serious events that may jeopardize the health or well-being of the subject or require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Serious Adverse Events and deaths must be reported to the FDA and the IRB: 21 CFR 803
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803&showFR=1&subpartNode=21:8.0.1.1.3.2