224 - AdventHealth | A Leader in Whole-Person Health Care
| |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 |Guidance for HDE Holders recommends that Continuing Review of Humanitarian Use |
|Tuesday. |Devices be conducted by Expedited Review. |
|Submissions should be provided to the IRB as follows: | |
|Via electronic format; or, |Section 47: |
|17 collated paper copies | |
| |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 Name - Trade: | |
|Device Name - Generic: | |
|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: |
|Site: | |Total Devices Used Since Last Continuing |
| |Total Devices Used Since IRB |Review: |
| |Approval: | |
| Florida Hospital Tampa | | |
| Florida Hospital Pepin Heart Institute | | |
| Florida Hospital Carrollwood | | |
| Florida Hospital Zephyrhills | | |
| Florida Hospital Connerton (LTAC) | | |
| Florida Hospital North Pinellas | | |
| Florida Hospital Wesley Chapel | | |
|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: |
|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 | |
| Florida Hospital Wesley Chapel | |
|Any unanticipated problems involving risks to patients? | |
|If yes, please explain: |Yes* No |
|Any deaths involved with use of the device? |Yes* No |
|Was the death related to the device? |Yes* No |
|Please describe the event and its relation to the device: | |
|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
-----------------------
END NOTES
| |
|[i] 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 |
| |
................
................
In order to avoid copyright disputes, this page is only a partial summary.
To fulfill the demand for quickly locating and searching documents.
It is intelligent file search solution for home and business.
Related searches
- united health care make a payment
- health care system in china
- changes in health care technology
- health care in china
- in home health care providers
- health care in the news
- in home health care aides
- health care problems in america
- health care issues in america
- what makes a leader a leader
- describe a leader in one word
- components of a health care system