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What is a Study Risk Determination?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

A Study Risk Determination is a request for FDA determination for whether a planned medical device clinical study is significant risk (SR), non-significant risk (NSR), or exempt from IDE regulations as defined by the IDE regulations (21 CFR part 812). For studies that are not exempt, sponsors are responsible for making the initial risk determination (SR or NSR) and presenting it to the Institutional Review Board (IRB). FDA is available to help the sponsor, clinical investigator, and IRB in making the risk determination. FDA is the final arbiter as to whether a device study is SR or NSR and makes the determination when an IDE is submitted to FDA or if asked by the sponsor, clinical investigator, or IRB.

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