Is my study significant risk or nonsignificant risk?
FDA has a guidance document to help explain how to determine whether a device study is significant or nonsignificant risk. If the sponsor believes a device study is nonsignificant risk, the sponsor can provide information to the IRBs reviewing the study explaining why the device study does not pose a significant risk. If the IRBs agree and approve the study, the research may be conducted and FDA does not need to be notified. However, if an IRB determines the study is significant risk, the sponsor must notify FDA in writing (21 CFR 812.150(b)(9)). The study may not begin until FDA approves the study or provides a determination that the investigation is nonsignificant risk.
Related Questions
- How do I determine if the study is a significant or non-significant risk study and how do I determine if an invasive sampling technique presents a significant risk under 21 CFR 812.2(c)(3)?
- What are my responsibilities as the sponsor or the investigator of a study of a significant risk device subject to 21 CFR Part 812?
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