Investigational Device Information

Institutional Review Board
Please complete only if applicable to your project and attach to the Application for Study
INSTRUCTIONS: The research investigator (or sponsor) should make an initial risk assessment (nonsignificant/significant risk) of a device based upon the use of the device with human subjects in a research
environment. If the IRB determines that the device poses significant risk to human subjects, the investigator
(or the sponsor) must obtain an IDE number from FDA and provide a copy of the IDE approval to the IRB.
All clinical investigations of devices must have an approved IDE or be exempt from the IDE regulation.
Investigations that are exempted from 21 CFR 812 are described in §812.2(c) of the IDE regulation. Studies
exempt from the IDE regulation include:
1. A legally marketed device when used in accordance with its labeling
2. A diagnostic device if it complies with the labeling requirements in §809.10(c) and if the testing:
a. is non-invasive;
b. does not require an invasive sampling procedure that presents significant risk;
does not by design or intention introduce energy into a subject; and
d. is not used as a diagnostic procedure without confirmation by another medically established
diagnostic product or procedure.
Additional guidance for an in vitro diagnostic device studies can be found in
"Regulating In Vitro Diagnostic Device (IVD) Studies."
3. Consumer preference testing, testing of a modification, or testing of a combination of devices if the
device(s) are legally marketed device(s) [that is, the devices have an approved PMA, cleared Premarket Notification 510(k), or are exempt from 510(k)] AND if the testing is not for the purpose of
determining safety or effectiveness and does not put subjects at risk.
Please attach three copies of the Investigator’s Brochure. Provide the following information on each
investigational device that is not approved by the FDA for the use outlined in the study protocol. If you intend
to use an approved device in an unapproved way (new age groups, new indications, etc.) in the research, and
if you are planning to use the results to seek FDA approval, you must submit an IDE application to the FDA.
Investigational Device Information Record
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Study Information
1. Protocol Title:
2. Participating investigators authorized to use the investigational device:
Primary Contact:
3. Study Sponsor:
Part A
1. Name holder of IDE and IDE Number:
(If not applicable, please check N/A.)
2. Is this device being used for the indication approved by the FDA?
3. Will any approved device be used for new indications or in unapproved
4. How is this device unique from other comparable products on the market?
5. Is this a device that is custom-made for use by a particular physician or for
a particular patient?
6. Manufacturer of device:
7. Has there been prior usage by others?
Where? When?
8. Study design:
Placebo control
Device Control
9. Approximate duration of investigation.
10. Approximate number of subjects needed.
Investigational Device Information Record
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Part B
1. Assessment of the Risk of Device to Participating Subjects:
Non-significant risk devices are devices that do not pose a significant risk to the human subjects. Examples
include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and Foley catheters.
A non-significant risk device study requires only IRB approval prior to initiation of a clinical study. Sponsors of
studies involving non-significant risk devices are not required to submit an IDE application to FDA for approval.
Submissions for non-significant device investigations are made directly to the IRB of each participating
institution. Sponsors should present an explanation to the IRB where the study will occur of why the device
does not pose a significant risk. If the IRB disagrees and determines that the device poses a significant risk,
the sponsor must report this finding to FDA within five working days [§812.150(b)(9)]. FDA considers an
investigation of a non-significant risk device to have an approved IDE when IRB concurs with the nonsignificant risk determination and approves the study.
Significant risk device is an investigational device that: (1) is intended as an implant and presents a potential
for serious risk to the health, safety, or welfare of a subject; (2) is for use in supporting or sustaining human life
and represents a potential for serious risk to the health, safety, or welfare of a subject; (3) is for a use of
substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing
impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a
subject; or (4) otherwise presents a potential for serious risk to a subject.
2. Indications for Use:
3. Possible Complications:
4. Precautions, Warnings, Side Effects and Contraindications:
5. Special Storage Requirements, if any:
Principal Investigator’s Signature
Investigational Device Information Record
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