CHECKLIST: Non-Significant Risk Device
The purpose of this checklist is to provide support for IRB Chairs, Vice Chairs, or designees following HRP-314 - WORKSHEET - Criteria for Approval when research involves an abbreviated IDE. This checklist must be used for all applicable reviews.For initial review modifications and continuing reviews where the determinations relevant to this checklist made on the previous review have changed, the Research Compliance Administrator completes this checklist to document determinations required by the regulations along with protocol specific findings justifying those determinations. The Research Compliance Administrator attaches this checklist to the “Submit Pre-Review” activity. The Chair, Vice Chair, convened IRB, or designee reviews the checklist to confirm the criteria have been met. The IRB Office retains this checklist in the protocol file.SIGNIFICANT RISK DEVICE STUDY (Check if “Yes”. If any are checked, the device is a significant risk device.)?Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject.?Is purported or represented to be for a use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject.?Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject.?Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.NON-SIGNIFICANT RISK DEVICE STUDY (Check if “Yes”.)?Meets none of the above criteria.RATIONALE (Describe) FORMTEXT ????? ................
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