How can you determine if an in vitro diagnostic (IVD) device is of significant risk?

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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.

About the Author
Proxima CRO Team
Dora Huang
Intern

Dora Huang is from Houston, TX and is a jack-of-all-trades. Dora is a Regulatory Affairs and Graphics Design Intern for Proxima. She has experience working on projects that vary from engineering water systems to tissue engineering.

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