Device Checklist
Reviewer
Submission ID
Principal Investigator
Protocol #
Device Checklist
Yes
I. Does the research collect safety and/or efficacy data on medical device(s) in
human subjects or on human specimens?
(if no, skip to section II below)
A. Does the study have an IDE?
If yes, indicate how the IDE # is documented:
Sponsor protocol imprinted with IDE #
(Investigator Brochure may not be used for this purpose)
Written communication from the Sponsor documenting IDE #
Written communication from the FDA documenting IDE #
(If there is an IDE, skip to section II below. If there is no IDE, continue to B)
B. The study does not have an IDE
If yes, is the project exempt from IDE regulations by one of the following?
All device(s) studied are FDA approved and used strictly according to
FDA labeling.
Only in vitro diagnostic device(s) are being studied, and testing is noninvasive and does not require an invasive sampling procedure
(venipuncture or leftover clinical samples are OK), and testing does not
introduce energy into subject, and results are not used for diagnosis
without confirmation by an established test
Device consumer preference testing, testing of a modified FDA-approved
device, or testing of a combination of two or more FDA-approved devices
(i.e., used in combination), as long as the testing is not for the purpose
of determining safety or effectiveness and does not put subjects at risk.
Custom device testing, as long as no safety/effectiveness data are
being collected.
(if study is exempt from IDE regulations, skip to D. If the study is not exempt,
continue to C)
C. IDE Regulations apply. Determine Device(s) Risk Level:
Full Board review required for device risk determination
1. At least one device in the study meets the definition of Significant Risk
Device:
• Device intended as an implant (30 days or more) OR used to support or
sustain human life OR is of substantial importance in diagnosing, curing,
mitigating, or treating disease or preventing impairment of human health
AND
device presents a potential for serious risk to subject’s health, safety, or welfare
COMIRB Device Checklist
CF-060, Effective 01/07/15
Protocol # ___________
1
No N/A or Comments
Device Checklist
Device Checklist
Yes
OR
• Device otherwise presents a potential for serious risk to subject’s health,
safety, or welfare
(If yes, IDE is required; discuss at meeting and skip to C3. If no, continue toC2)
2. All devices in the study are Non-significant Risk Devices because none
meet the above definition of Significant Risk Devices.
If all devices are Non-significant risk, the answers to a & b must both be yes:
a. Device(s) are not banned by the FDA
b. The Sponsor (or Sponsor-Investigator) will follow the abbreviated IDE
requirements in 21 CFR 812.2 (b). Has the investigator indicated these
will be followed [see Attch D, section 2, #B2(c)]
(Continue to D)
D. Is the study consistent with FDA Informed Consent requirements by
one of the options below?
Informed consent is obtained from each subject for the research
All devices studies are exempt from IDE regulations and data will not be
submitted to FDA; therefore, study is not FDA-regulated and 21 cfr 50
does not apply. Consent will be considered under 45 cfr 46.116.
All devices studied are exempt from IDE regulations and only
anonymous biological samples that are leftover from clinical care or
another research study will be used; therefore, study is subject to FDA
enforcement discretion of 21 cfr 50.
(Continue to section II)
II. Does the protocol involve an HUD under an HDE?
(if no, skip to section III below)
A. Does the study have an IDE?
If yes, indicate how the HUD and/or HDE # are documented:
Sponsor protocol imprinted with HUD and/or HDE #
(Investigator Brochure may not be used for this purpose)
Written communication from the Sponsor documenting HUD/HDE #
Written communication from the FDA documenting HUD/HDE #
B. Will safety or effectiveness about the HUD data be collected?
If yes, IDE regulations apply. If the device is investigated strictly according
to its FDA labeling (in terms of indication, population, and how the HUD is
applied to the subject), it is exempt from the IDE regulations. Complete
section I above, and make risk determination, if necessary. Discuss at
meeting.
COMIRB Device Checklist
CF-060, Effective 01/07/15
Protocol # ___________
2
No N/A or Comments
Device Checklist
Device Checklist
Yes
If no, this means the HUD is only being used to clinically treat patients. If
this is the case, is the HUD used strictly according to its FDA labeling (in
terms of indication, population, and how the HUD is applied to the subject)?
(If yes, to section III)
C. Off-label use of an HUD
If the HUD is to be used off-label, does the off-label use increase risks, or
decrease the acceptability of deivce risks, to the patient?
Discuss your determination at the meeting. If risks are increased to patients
through off-label use, the IRB can require the PI collect safety data to evaluate
risks of the proposed use. If the IRB requires that these data be collected,
complete section I above and make a risk determination to determine whether
an IDE is required.
(Continue to section III)
III. Is the plan to securely store, dispense, and dispose of the device(s) in this
study appropriate?
ADDITIONAL NOTES:
Sign Here
__________________________________________
Reviewer Signature
__________
Date
Signature above verifies this checklist was used in the review of this protocol.
COMIRB Device Checklist
CF-060, Effective 01/07/15
Protocol # ___________
3
No N/A or Comments