Special considerations for Device Research
The FDA regulations establish additional requirements on the part of the IRB for
the review of studies using medical devices. Before reviewing research involving
a device, the Board must determine whether the device study qualifies as a Non-Significant
Risk (NSR) Device study, a Significant Risk (SR) Device study, or whether the research
use of the device is exempt from the IDE regulations. In the WIRB submission form,
please indicate if you consider the device study to be NSR, SR, or otherwise exempt.
If you believe that the device is NSR and the Board agrees, then the Board may go
on to review the research. However, if the Board disagrees, and finds the study
to be SR, and there is no IDE assigned, it will provide the investigator and, if
appropriate, the sponsor, with its finding. The sponsor is responsible for notifying
the FDA of the Board's SR determination. The Board will not review the research
until the sponsor provides written proof that either the FDA has granted an IDE
to the sponsor or that the FDA disagrees with the Board's SR determination and has
determined that the device is NSR. If the FDA has not responded to the IDE application,
as described in FDA 21 CFR § 812.30, this proof may consist of a letter
showing that an IDE application was submitted at least 30 days prior to the date
on which the submission was forwarded to WIRB.
If the research is SR, provide WIRB with proof of the IDE number at the time of
submission. The Board will automatically consider the research to be SR.
Note: If the subject must undergo a medical procedure as a part of the study, and
that medical procedure is not one which the subject would otherwise undergo as part
of standard medical care, the Board must consider the risks associated with the
procedure as well as the use of the device. If potential harm to subjects could
be life-threatening, could result in permanent impairment of body function, or permanent
damage to body structure, the device should be considered SR.
If the Board determines that the investigation meets one of the IDE exemptions listed
at 21 CFR § 812.2(c), this finding will be noted in the minutes,
and the Board will not make an SR/NSR determination. Also, if the investigation
involves a device that is cleared for marketing through the PMA process, and the
device is being studied for the purpose(s) for which the device is labeled, the
Board will consider the investigation exempt from the IDE regulations.
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