This message was posted by a user wishing to remain anonymous
I was asked by a member of the research team whether we needed to submit our routine expanded access compassionate device request through our e-mostly research & some EAP project tracking system and have IRB review. The research team member mentioned the IRB Chair had already said it was okay but there is nothing logged in our e-system. The NSR device is still investigational and non-cleared, submission has not even started yet. Normally these EAP types of requests follow a set process including IRB review and e-system logging. One of the investigators indicated no IRB was needed and no e-system was needed.
The Agency guidance doc contains a statement about NSR devices:
From FDA guidance -https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127067.pdf (pg 9) B. Non-Significant Risk Device Studies: An NSR device is an investigational device that does not meet the definition of a significant risk device. If an IRB finds that an investigational medical device study poses a NSR, the sponsor does not need to submit an IDE to FDA before starting the study. If the IRB determines that the proposed study is an NSR study, the IRB may proceed to review the study under 21 CFR 56.109 and 21 CFR 56.111. FDA considers an NSR device study to have an approved IDE after IRB approval and when sponsors meet the abbreviated requirements at 21 CFR 812.2(b). Consequently, in most cases, FDA is not aware of non-significant risk device studies.
Is this permissible? To use an investigational device without IRB review & approval? Thank you!