Submit this completed form (with original PI signature) to the IRB office (Box 817 or 15 Kneeland St, 1st floor)
PRINCIPAL INVESTIGATOR:
STUDY TITLE:
List all:
· Devices being evaluated for safety or effectiveness
· Humanitarian Use Devices (HUD)
· Submit product labeling for each item listed (also see below for supporting documents) / Significant risk (SR) device / Non-significant risk (NSR) device / Attach documentation that explains why the device is significant or non-significant risk[1]. For an SR determination, this may include a copy of the IDE approval or conditional approval letter from FDA. For an NSR determination, this may include the FDA's or study Sponsor’s NSR determination. (Attach additional pages as needed).
Protocol is being conducted: / Under IDE / IDE/HDE# / Submit evidence of IDE/HDE#[2]
Under HDE
Under abbreviated IDE requirements
None of the above (Specify:)
Who holds the IDE/HDE? / Sponsor
Investigator / Submit approved IDE/HDE application and FDA approval letter for IDE/HDE#
Other (Specify:)
Costs / Specify who will be responsible for the cost of the device / Cost of the device (if device is not provided free of charge) $
Implantation of Device / Will the device be implanted or placed in the body? Yes No
If Yes, who will be responsible for the costs of implantation or placement of the device?
Explantation of Device / Will the device be removed from the body? Yes No
If Yes, who will be responsible for the costs of removal from the body?
Please note: Plans for explantation, including who will cover costs associated with this, should be described in the ICF.
Supporting Documents
(submit all available supporting documents) / Operator’s Manual
Manufacturer’s Booklet
Diagrams of the device
Promotional Materials / Subject handouts
Device Warranty
Other (please describe)
______
Signature of Principal Investigator Date
THE PRINCIPAL INVESTIGATOR IS TO RETAIN A COPY OF THIS COMPLETED FORM IN THE STUDY FILES
NUMBER / VERSION DATE / PAGEHRP-203 / 08/29/2017 / 1 of 2
NUMBER / VERSION DATE / PAGE
HRP-203 / 08/29/2017 / 1 of 2
[1] The judgment about whether a study poses a significant risk or non-significant risk is based on the significance of the potential harm that may result from participation in the study, including the use of the device. Sponsors are responsible for making the initial risk determinations and the PI should submit this to the IRB. If the sponsor identifies this device as non-significant risk, the sponsor will have to provide the IRB with an explanation of its determination and any other information that may help the IRB in evaluating the risk of the device as proposed for use in the research study (for example, a description/specifications of the device, why the device qualifies as non-significant risk, and if available, reports of prior investigations with the device). If the FDA has already determined that the device, as used in the research study, is non-significant risk, the sponsor can provide this as documentation.
[2] Acceptable evidence includes: Sponsor protocol imprinted with the IDE#, sponsor documentation that indicates the IDE#, or FDA documentation that indicates IDE#