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UF Health University of Florida
Clinical Research Hub Formerly the Office of Clinical Research
OCR is now the Clinical Research Hub @ the College of Medicine
Intake Resources Overview

Device Table

Always download and save the latest version of any form or resource from this website before compiling study documents.

Purpose

  • Documents all specifically-named, non-generic medical devices (investigational or non-investigational) required by the protocol
  • Used by the Office of Clinical Research to help identify research billing and contractual risks associated with the use of protocol-required devices in research
  • The device table is NOT shared with the IRB or FDA.

Instructions

1) In the header, type in the Study Nickname (i.e. the name your study team uses to reference this protocol).

2) For each device, enter or select the following:

  • Name/Description of the device as it is referenced in the protocol.
  • FDA Device Type (select from drop-down)
    • *IDE Category A – Experimental – confirm with sponsor’s FDA IDE letter for this study
    • *IDE Category B – Non-experimental / Investigational – confirm with sponsor’s FDA IDE letter for this study
    • *Carotid Artery Stent
    • PMA – PreMarket Notification
    • 510(k) – Cleared for Use
    • 510(k) Exempt
    • NSR (Non-significant Risk) – IRB must agree that this device study presents a non-significant risk
    • FDA Approved (On Market)
    • FDA Approved for Off Label Use – confirm with FDA letter
    • HUD/HDE – Humanitarian Use Device / Humanitarian Device Exemption – confirm with FDA letter
    • Other – Describe in Comments
  • FDA # (for IDE or CAS Devices Only) – Confirm with FDA letter
  • Funding Source (select from drop-down)
    • *Billed to Patient/Insurance
    • Provided by Sponsor
    • Billed to Sponsor/Study
    • Department Owns
    • Other – Describe in Comments
  • Location of Device Use (select from drop-down and specify details in comments)
    • **Shands
    • UFHP Clinic
    • Research Space
    • UF CRC
    • Other
  • Does Shands Need to Purchase/Receive?
    • **Yes or No
  • Storage Location (select from drop-down)
    • Secured Research Space
    • UF CRC
    • UFHP Clinic
    • **Shands OR
    • **Shands Clinic
    • **Shands Storage Area
    • Other, Describe in Comments

Other Reviews/Policies That May Apply to Your Device

If any of your drop-down selections has a single * or double asterisk **, carefully read and follow the associated guidance at the bottom of the form. This is especially important if your study billing plan includes billing patients/insurance in an IDE or CAS study.  

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