What types of devices need to be included in the eIRB application?
(1) Unapproved devices, (2) all investigational devices, meaning all those being studied for their safety or effectiveness regardless of whether they are FDA-approved/cleared or not, and (3) FDA-approved/cleared devices that are not approved for use for clinical use at CHOP.
How do I include a device in the eIRB application?
Check the "Device" box in Section 5.04 (2.0). This will then require completion of Section 8.02. The information about the device - e.g. brochures, manuals, 510(K) clearance approval letters - should all be attached in Section 12.02 (3.0). Risk information should be included in the protocol, consent form and in eIRB Section 11.01 (1.0).
The device is not a physical instrument, it's medical software, a diagnostic test/assay, an MRI sequence, or a medical app. What type of storage plan is required?
There needs to be a plan that explains how the use of the device is only used for this research study and that will limit access to members of the investigative team. For example, there needs to be a plan to limit the use of unapproved MRI sequences so that they are not used for clinical care.
Who decides whether a device is non-significant risk or significant risk?
The sponsor is responsible for making the initial NSR-SR determination. The IRB is responsible for reviewing and concurring with or disagreeing with, the sponsor's assessment. If the sponsor has a letter from the FDA indicating that the device is NSR, the IRB must accept that decision (the FDA's determination is final). Otherwise, if the IRB disagrees with the sponsor's determination that the device is NSR, the sponsor must request that the FDA issue its opinion.
If the IRB has determined that the device meets the definition of an NSR device, do I need to get an IDE from the FDA?
No. If the IRB concurs with the sponsor's NSR determination, then it is effectively issuing an abbreviated IDE to conduct the study. NSR device studies must follow the abbreviated requirements under 21 CFR 812.2(b) and the FDA's regulations for Human Subjects Protections and the IRB operations (21 CFR 50 and 56).
My sponsor initially determined my device is NSR but the IRB determined it was SR. What do I need to do?
The sponsor must obtain one of the following from the FDA: (1) a determination that the device is an NSR device or (2) an IDE (in the event the FDA agrees that the device is an SR device).
My sponsor initially determined the device is an SR device. Can I submit the study to the IRB for review if the FDA hasn't issued the IDE yet?
Yes. However, the IRB will not release its final approval until an IDE has been issued and documentation, including the IDE number, has been provided to the IRB.