Attachment D:
Use of Devices
COMIRB #:Approval Stamp here:
Principal Investigator:
Protocol Title:
Version date:
Whether or not a study utilizing devices falls under FDA regulation depends on whether or not data will besubmitted to the FDA or safety and/or effectiveness data are being collected on a medical device. Safety or effectiveness data are collected if evaluating the device’s safety/abilitytodiagnose (predict), treat, prevent, cure or mitigate a disease, ORaffect the structure or function of the body. In contrast, devices used as a tool to collect data to examine a physiologic principle are not subject to FDA regulations. If you are seeking an Emergency Waiver of informed consent for this project, or please contact the COMIRB Director (303-724-1058) before completing this form.
Please categorize all devices used in this study below, based on the following examples:
Safety/Efficacy Data collected on the device:
- Device’s ability to decrease symptoms in patients with Xdisease
- Device studied for its safety in identifying patients with X,Y,Z constellation of symptoms
- Device used to predict future occurrence of condition X
- Device’s ability to improve X function (e.g., intestinal motility, attention span, grip strength)
Device used as a tool to collect physiology data:
- Device used to measure liver size in patients with X vs. controls
- Device used to cool skin to see if erector pili muscle function differs in people with X vs. controls
- Device measures X function (e.g., intestinal motility, attention span, grip strength) to see how symptomatic patients differ from asymptomatic patients
List each device used in this study in the appropriate column. Any devices for which data will be submitted to FDA should also be listed in column 1. For devices in columns 1 and 2 only, provide information on the subsequent pages. Use the device number (e.g., 1-2, 2-1) in these columns to delineate answers to each question for each device on the following pages.
COLUMN 1Safety/efficacy data collected
(device FDA-approved or not) or data to be submitted to FDA / COLUMN 2
Other device use
(HUD, compassionate use) / COLUMN 3
Devices used as a tool to collect physiology data
(FDA-approved or not)
1-1. / 2-1. / A.
1-2. / 2-2. / B.
1-3. / 2-3. / C.
1-4. / 2-4. / D.
1-5. / 2-5. / E.
For each device in this column, complete sections 1-3 on the following pages / For each device in this column, complete section 4 on the following pages / Do not complete the rest of this form for devices in this column. COMIRB must evaluate the risks these devices pose to subjects. Submit supporting documents that describe the device risks, unless very familiar to COMIRB (e.g., DEXA, CT scan, EKG). If all study devices are under column 3 only, submit page 1 only.
For each device listed in column 1on page 1, please complete sections 1-3 and 5 below. For each device listed in column 2 on page 1, please complete sections 4 and 5 below.
Section 1. Describe Devices (all devices in column 1 must appear under A, B or C)
A. FDA-Approved Medical Devices Being Used According to Written Labeling
Device Name(s):
Manufacturer(s):
1) Is eachdevice provided at not cost to the subject by the sponsor?
Yes No
If no, detail:
2) Do any of the devices create, or publish, electronic data about the subject (e.g., glucose meters, holter monitors, EKGs)?
Yes No
If yes, describe how the data will be collected, stored, and secured. Please also describe the how this data will be used in the research.
3) Provide supporting documentation of FDA approval for each device (package insert, 510k, or product information) so that the committee can review the approved uses and populations, as well as device risks.
B. FDA-Approved Medical Devices Being Used Off-Label
Device Name(s):
Manufacturer(s):
1) Is each device provided at not cost to the subject by the sponsor?
Yes No
If no, detail:
2) Does each device create, or publish, electronic data about the subject (e.g., glucose meters, holter monitors, EKGs)?
Yes No
If yes, describe how the data will be collected, stored, and secured. Please also describe the how this data will be used in the research.
3) Describe how the use of the device in this study differs from its FDA-approved labeling.
4) Provide any supporting documentationso that the committee can assess how the use of the device in this study differs from its approved labeling, as well as the device risks.
C. UnapprovedMedical Devices
Device Name(s):
Manufacturer(s):
1) Is the device provided free of charge by the sponsor? Yes No
If no, detail:
2) Does the device create or publish electronic data about the subject?
Yes No
If yes, describe how the data will be collected, stored, and secured:
3) Provide anysupporting documentation needed for the committee to review the device risks.
Section 2. IDE Compliance (all devices in column 1 must appear under A or B)
A. Devices used under an IDE
1)Which device(s) used under an IDE:
2)Provide evidence of the IDE:
Either
A copy of the sponsored protocol imprinted with the IDE number
Yes No
Or
Written communication from sponsor documenting the IDE number
Yes No
Or
Written communication from the FDA documenting the IDE number (Required if the investigator holds the IDE)
Yes No
3) Who holds the IDE?
Sponsor Yes No
Investigator Yes No
If the Investigator holds the IDE, is the PI aware of the applicable FDA regulations at 21 CFR 812 (Subparts C and E), and will the PI ensure that research is conducted according to the signed agreement and the approved protocol? This is required if the PI holds the IDE.
Yes No N/A
B. Devices without an IDE. If there is no IDE, the device must either be exempt from IDE regulations (section 1, below) or meet the definition of a Non-significant Risk device (section 2, below); otherwise, list the device in section 3 below and obtain an IDE from the FDA.
1) Which device(s) are Exempt from IDE regulations:
An IDE is not required for a device that is not approved by the FDA if the conditions in any of the following categories are met [21 CFR 812.2(c)].
Provide documentation establishing that the clinical investigation of the medical device falls within one of the following categories:
a. Clinical investigation of a medical device that is FDA-approved, where the device is being used or investigated in accordance with the indications described in the FDA labeling. Safety or effectiveness comparisons of two or more FDA-approved devices are not eligible for this category.
b. A clinical investigation involving a Diagnostic Medical Device if it complies with FDA labeling requirements and if the testing: (a) is noninvasive; (b) does not require an invasive sampling procedure that presents significant risk; (c) 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.
c. Consumer preference testing, testing of a device modification, or testing of a combination of two or more FDA-approved devices, if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk.
d. A custom device as defined in 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution.
2)Which device(s) are Non-significant Risk Devices:
a. Answer the followingto determine non-significant risk:
i. Is the device is intended as an implant (≥30 days)?Yes No
ii. Is the device purported or represented to be for use supporting or sustaining human life? Yes No
iii. Is the device for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health? Yes No
iv. If yes to i, ii, or iii above, does the use of the device in this setting present a potential for serious risk to the health, safety, or welfare of a subject? [if yes to this question, this is a Significant Risk device; please insert device name under B3 below] N/A Yes No
v. Does the device use in this study otherwise present the potential for serious risk to the health, safety, or welfare of subjects? Yes No
vi. Describe whythe use of the devicedoes not pose a potential for “serious risk” to subjects in this study (i.e., if it were to fail or not work as expected):
b. If Non-significant Risk, verify that the Sponsor (or the PI if there is no external sponsor) will follow the abbreviated IDE requirements in 21 CFR 812.2 (b):
The device is not bannedYes No
And
The sponsor will label the device in accordance
with 21 CFR 812.5 Yes No
And
The sponsor will comply with the requirements of 21 CFR 812.46 with respect to monitoring investigators Yes No
And
The sponsor (or investigator) will maintain the records required under
21 CFR 812.140(b) (4) and (5) and make the reports
required under 21 CFR 812.150(b) (1) through (3)
and (5) through (10).Yes No
And
The sponsor will ensure that participating investigators maintain the
records required by 21 CFR 812.140(a)(3)(i) and make the reports
required under
21 CFR 812.150(a) (1), (2), (5), and (7).Yes No
And
The sponsor (or investigator) will comply with the prohibitions in 21 CFR 812.7 against promotion and other practices. Yes No
3) Which device(s) can not be listed inB1 or B2above?:
A significant risk device: If the use of the device does not fit the definition of Exempt (i) or Non-significant risk device (ii) above, IDE approval from the FDA is required prior to submission to COMIRB. Please submit IDE application to the FDAand provide documentation of the IDE to COMIRB.
Section 3. FDA Informed Consent Compliance
One of the following choices must be checked:
A. Informed consent regarding the investigation of device(s) is obtained from every subject
B. No informed consent: devices studied are exempt from IDE regulations and data from this research will not be submitted to FDA
C. No informed consent: Devices studied are exempt from IDE regulations and the study will use only anonymous samples left over from clinical care or another research study
Also complete section 5
Section 4.Humanitarian Device (HUD)
A) For each HUD approved device indicate:
- Name
- Mechanism of action
- Manufacturer
Describe:
B) Does the device have a Humanitarian Use Device Exemption (HDE)?
Yes No
If yes, please provide HDE# :
C) Provide evidence of the HDE either (include with submission):
Letter from the FDA granting HUD status Yes No
Or
Letter from the FDA granting HDE to local PI Yes No
D) Will safety or effectiveness data be collected in this protocol about the use of any HUD listed above? Yes No
1. If yes, for which HUD(s)?
2. If yes, will all of the HUDs for which you are collecting data be used strictly according to their FDA-approved labeling, including indications for use, subject age range, and how the HUD is used/applied? Yes No N/A
If you answered “no” to #D2, you would be proposing an investigational study of the HUD. You must also indicate that you are collecting safety/effectiveness data in the Table on page 1 of this form. An IDE will be required from the FDA prior to submitting this protocol if the HUD meets the definition of a Significant Risk Device, which essentially all HUDs do.
E) Will any HUDs listed above be used to treat patients only? Yes No
1. If yes, will these HUDs be used strictly according to their FDA-approved labeling,including indications for use, subject age range, and how the HUD is used/applied? Yes No N/A
If you answered “no” to #E1, be aware that HUDs are FDA-approved only for use within their approved labeling. The IRB must assess the risks to patients that the off-label use poses. The IRB may require that safety or effectiveness data be collected to assess these risks; in this case, an IDE would likely be required, since essentially all HUDs meet the definition of Significant Risk Devices. Answer the following questions to assist with the IRB’s assessment:
a)Which HUDs will be used off-label?
b)Detail how the use of each HUD differs from its FDA-approved labeling:
c)Detail how this alteration affects risks to patients for each device:
F) Confirm that the HUDs will be used only as described in the protocol, in terms of the indications for use, patient population(s), and how the HUD is used/applied to the patient (this is a requirement for HUD use):
Yes N/A
F) Will patients, or their insurance, be billed for the HUD use?
Yes No
If yes, detail:
G) Does the device create, or publish, electronic data about the subject?
Yes No
If yes, describe how the data will be stored and secured:
Also complete section 5
Section 5.Device Control and Storage
A)Describe the plan for storing and dispensing the device to ensure that only appropriate personnel have access to the device:
B)Describe the plan for the handling each device so that only subjects who have provided consent receive the device:
C)Describe the plan for the disposal of the products to be used:
Attachment D: Use of Devices
CF-093, Effective 8/29/11Page 1 of 7