In response to my last post, I found sponsor responsibilities after the significant risk (SR) versus non-significant risk (NSR) determination.

If the IRB decides a study is SR, the sponsor must:

Submit IDE to FDA
Not begin the study until the FDA approves the IDE and the IRB approves the study
Comply with IDE regulations and informed consent and IRB regulations.

If the IRB decides a study is NSR, the sponsor must:

Comply with “abbreviated IDE requirements” and informed consent and IRB regulations.

IDE is an investigational device exemption that “allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data”. The following link provides an entire list of IDE responsibilites:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm046702.htm

I find it vague that the difference between a SR study and NSR study is “comply with IDE regulations” versus “comply with abbreviated IDE requirements”. Does anyone have any commentary on this or experience with it? According to the wording it seems like both need to follow IDE responsibilities so why is being classified as a SR device a lot harder to pass through?

Resource: https://cphs.berkeley.edu/checklists_worksheets/nsrdevice.pdf