IRB-01
HELP
Are you conducting human research?
Submit a NEW STUDY
TOOL: Research on Medical Records, etc.
REVISE/AMEND your research
Submit an ADVERSE EVENT
Submit a DEVIATION / NONCOMPLIANCE
Submit an UNANTICIPATED PROBLEM
Submit a HDE (Humanitarian Device Exemption)
Submit EMERGENCY USE
Submit a CONTINUING REVIEW
Do you need approval for Case Reports?
Which IRB do you submit to?
 
 
 

Submit a NEW STUDY

HDE stands for Humanitarian Device Exception, and it is an approval category that the Food and Drug Administration (FDA) grants to permit the use of certain devices known as Humanitarian use Devices or HUDs.

HUDs are not like other FDA approved devices. According to federal regulations a physician must obtain IRB approval prior to using a HUD. HUDs can be used in two different ways:

  (A) for treatment purposes only (e.g. not to answer a research question or to collect any information for publication purposes); OR
  (B) as part of a research protocol.

  Submit:
  • If you only wish to use the HUD for treatment purposes, submit our HDE-New Study paperwork along with a copy of the sponsor's sample Informed Consent form. Additional paperwork is needed and is described in our form.
  • If you wish to use the HUD as part of a research protocol you must submit Full Board paperwork. See Submit a NEW STUDY and note in particular the requirements listed under category IV on page 2.

NOTE: the IRB approval for HDEs is at most a year (it may be shorter). You must submit a Continuing Review and receive approval in order to continuing the device, to use the device in new patients, or to collect data on previously deployed devices.

 

Copyright 2007 - Updated: 06/11/2007 9:45 AM
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