/ ZIPLINE SUPPLEMENT: Devices /
PURPOSE and INSTRUCTIONS /
This form is a supplement to IRB applications that are submitted through the Zipline IRB application system.
Answer the questions for the device. If you are using more than one device, copy and paste the table for each device or complete another form. (To copy the table, hover your cursor in the upper left hand corner above “Questions”. Click on the four-headed arrow that appears. Right click and select “Copy”. Go to the end of the form, add a few spaces, and right click and select “Paste”.). To check a box, place an “X” in the box. To answer a text box question, make sure your cursor is in the gray text field before typing or pasting content.
Study Title:
QUESTIONS /
1. Device name. What is the name of the device?
2. FDA status. On the Zipline SmartForm part of this application, you are asked to indicate on the “devices” page whether the use of this device for this study has an IDE, HDE, abbreviated IDE, or is exempt from the IDE requirements.
If there is an IDE or HDE: into which Medicare reimbursement category has the device been classified? (This is often indicated in the IDE approval letter from the FDA to the sponsor.)
Category A - Experimental
Category B – Investigation, non-experimental
Not yet classified
Abbreviated IDE or IDE Exempt. If there is an abbreviated IDE or this use of the device is exempt from the IDE requirements: provide your rationale for why an IDE or HDE is not required. Upload to Zipline any relevant correspondence you may have (if any) from the FDA, a sponsor, or coordinating center.
See the WORKSHEET: FDA Devices and the IDE Requirement for information about which types of device research qualify for an abbreviated IRB or are exempt from the IDE requirement. If you are not planning to submit the data to the FDA, state so here (as rationale for why an abbreviated IDE or IDE exemption is not required).
3. Implanted devices. Is this a device that will be implanted in the participants?
No
Yes / à 3.1. If yes, Who will implant the device?
3.2. Has this person had any experience or training with implanting this device?
Yes / à If yes, describe the relevant training and/or experience:
No / à If no, describe the qualifications that make this person appropriate for doing the implantation:
3.3. What facility will be used for the device implantation procedures? (e.g. Harborview OR)
3.4. Will the device be removed as part of the study (e.g. when the study has been completed)?
Yes
No / à If no, describe how you will handle a situation, if one arises, that requires the removal of the device (a) during the study; and (b) after the study has been completed.
Who will pay for the removal and any follow-up?
4. Source of the device. Who is providing you with the device for this research use?
Commercial manufacturer (such as a device company).
Name and/or describe:
A non-commercial manufacturer (such as a research lab – your own or someone else’s) or a non-profit that is making it (e.g. PATH).
Describe who, where, how, and when:
Other
Describe who, where, how, and when:
5. Assessment of risks. Describe how you developed your understanding of the risks of using the device for the purpose and in this population.
Examples: literature search from 1970 through the present; investigator provided by the manufacturer. Note that the IRB may require you to provide the citations for any literature you reviewed.
For devices that require an IDE or HDE. Has the FDA made a determination as to whether the device is Significant Risk, or Non-Significant Risk? Risk is based on the specific use of the device as defined for your study and your study population.
Yes / à If yes, attach documentation of the determination (such as correspondence from the FDA).
No / à If no, has the sponsor made a determination as to whether the device is Significant Risk or Non-Significant Risk?
“Sponsor” does not mean the agency or organization that is funding the research. Instead, it is defined by the FDA as the “persons, company, organization, or other entity that initiates and takes responsibility for a clinical investigation using an FDA-regulated item.” If you are the sponsor, the FDA requires you to provide the IRB with your risk assessment (significant risk or non-significant risk) of the device and your rationale.
Yes / à If yes, provide documentation of the sponsor’s risk determination.
No / à If no, provide any information you think may assist the IRB in making a determination of the risk of the device in this study. (Attach or describe below).
6. Is the FDA requiring the device manufacturer to track this device? In general, this is required for devices (1) which are intended to be implanted in the human body for more than one year; or (2) which is a life sustaining or life supporting device used outside a device user facility; or (3) the failure of which would be reasonably likely to have serious adverse health consequences. When tracking is required, it must be performed for the useful life of the device, or until the device is returned, destroyed, explanted or the patient dies. See the FDA Guidance.
No
Yes / à If yes, describe your procedures for tracking subjects and the device. You procedures (and the consent form) should allow for the FDA’s recognition that patients may refuse to have their device(s) tracked.
7. Do you anticipate that the device will require adjustments or changes?
No
Yes / à 7.1. If yes, describe the nature of the adjustments/changes, their purpose, and the possible impact on the risk and benefits of the device:
à 7.2. Will representatives from the device manufacturer (1) participate in or advise on the adjustment/changes, or (2) will they be present during the study procedures?
No
Yes / à If yes, describe their role:
8. Device control. The research team is responsible for ensuring appropriate control (e.g., locked storage), tracking (e.g., serial numbers), documentation, and return/disposal. Describe your plan for storage, control, and dispensing of the device so that (1) only authorized investigators will use the device; (2) they will use the device only in subjects who have provided consent; and (3) there will be documented tracking of each device, including unique identifiers and any return/disposal.
05/16/2017 / ZIPLINE SUPPLEMENT: Devices / #2008 /
Version 1.2 /
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