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To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC 1
IN VITRO DIAGNOSTIC PRODUCTS (IVDs) Developed by: U-MIC University of Michigan IRB Collaborative
IVDs In vitro diagnostic (IVD) products • defined by FDA at 21 CFR 809. 3(a) • • • “…reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. ” “…intended for use in the collection, preparation, and examination of specimens taken from the human body. ” FDA’s definition of subject includes individuals on whose specimens an investigational device is used. • IVD study using human specimens involves human subjects. Developed by: U-MIC 3
IVDs IVD studies that are exempt from IDE requirements • • sponsor follows labeling requirements at 21 CFR 809. 10(c) testing • • • is noninvasive does not require invasive sampling procedure posing significant risk does not introduce energy into subject is not used as diagnostic procedure without confirmation by other diagnostic product/procedure Other FDA regulations apply (21 CFR 50 and 56). Developed by: U-MIC 4
IVDs IVD studies that are subject to IDE requirements • • sponsor must • • make significant/non-significant risk assessment obtain approved IDE before research may begin • significant risk device IDE requirements depend on device risk assessment. • sponsor must • • • have IDE application approved by FDA follow all IDE regulations at 21 CFR 812 non-significant risk device • sponsor must meet abbreviated requirements at 21 CFR 812. 2(b) • • • Developed by: U-MIC monitoring IRB review and approval of the study compliance with informed consent requirements 5
IVDs IVD study goals • same as other device studies • • even if IVD study is exempt from most IDE requirements at 21 CFR 812. 2(c)(3) FDA recommends that IVD studies be conducted • to produce evidence demonstrating reasonable assurance of safety/effectiveness • Developed by: U-MIC while protecting subjects’ rights/welfare 6
IVDs in clinical investigations of therapeutic products • • Examples of therapeutic products include • • drugs biologics • • • select/classify subjects assign subjects to therapeutic product arms/doses monitor response to treatment IVDs used to guide management of subjects may pose additional risk to subjects subject additional requirements/oversight Developed by: U-MIC 7
IVDs In vitro diagnostic products (IVDs) Developed by: U-MIC 8
THANK YOU. Purna Garimella Brian Seabolt IRBMED Developed by: U-MIC 9
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