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How can you determine if an in vitro diagnostic (IVD) device is of significant risk?
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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 significant risk IVD device is generally one that is used for diagnosing, curing, mitigating, or treating disease and presents a potential for serious risk to the health, safety, or welfare of a subject. Potential serious risk is described to be misdiagnosis or error in treatment that results in permanent or fatal damage. This can come in the form of false positive results or false negative results. False positive results can lead to unnecessary treatment or confirmatory testing while false negative results can lead to a delay in establishing the correct diagnosis or delay in treatment.

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