An IVD Study Primer – Part I

Our medical device clients often ask us for assistance in understanding the ins and outs of in-vitro diagnostics. We’ve put together a multi-part primer on IVD studies that is designed to cover what medical device manufacturers need to know about this sector of the industry.

At their core, IVD studies are not significantly different from other medical device studies, as they aim to gather evidence about the safety and efficacy of a product in an ethical manner. The FDA classifies IVDs as reagents, instruments, and systems used in the diagnosis of diseases and the determination of a state of health. This can include products which are used to collect, prepare, or examine specimens from patients.

From the FDA’s perspective, IVD studies can be exempt from IDE requirements (21 CFR 812) under certain circumstances when all the following criteria are met: the IVD itself is non-invasive, the IVD does not require an invasive sampling procedure that presents significant risk to the patient, the IVD does not introduce energy into a subject, and the IVD does not stand alone as a diagnostic product or procedure. If all the above criteria are met and the investigational device is properly labeled, an IDE exemption can be obtained.

It’s important for medical device companies to understand exactly what the FDA is referring to with each of the specific IDE exemption requirements. An IVD is considered ‘non-invasive’ if it does not actually pierce or otherwise enter the body past certain limits if introduced via a canal or cavity. Testing that requires blood drawn from a vein is also considered non-invasive, as well as the use of ‘surplus’ tissue and fluid samples gathered for non-investigational purposes.

Likewise, the FDA considers an IVD that poses ‘significant risk’ to a study participant to be any device that plays a substantial role in determining or treating a health condition, or which could itself be detrimental to the health of a patient. This includes the potential for misdiagnosis resulting from IVD use and false positive results that can lead to unnecessary confirmatory testing and/or treatment. IDE exempt trials must not rely on any data gathered during the course of testing to make treatment or clinical decisions. Instead, personnel must employ an already-established means of diagnosis when managing the health condition in question.

All IVD studies must follow FDA labeling requirements, with the device in question bearing a disclaimer that states “For Investigational Use Only – The performance characteristics of this product have not been established.” IVD studies must also adhere to the same human subject protections as any other clinical trial as described in 21 CFR, Parts 50 and 56 (“Protection of Human Subjects” and “Institutional Review Boards”). This includes the de-identification of any leftover human specimens.

In our next post in the IVD series, we will take a look at protocols, plans, and data validity as applied to IVD studies.

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Lisa Dye
Benjamin Hunting
Aptiv Solutions Blogging Team