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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
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.

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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