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Questions and Answers
Which regulatory agency is responsible for overseeing IVDs in the United States?
Which regulatory agency is responsible for overseeing IVDs in the United States?
- World Health Organization (WHO)
- Food and Drug Administration (FDA) (correct)
- European Commission (EC)
- Centers for Disease Control and Prevention (CDC)
How many classes does the FDA classify IVDs into based on their risk?
How many classes does the FDA classify IVDs into based on their risk?
- Six
- Five
- Three (correct)
- Four
Which regulatory agency is responsible for overseeing IVDs in the European Union?
Which regulatory agency is responsible for overseeing IVDs in the European Union?
- World Health Organization (WHO)
- Food and Drug Administration (FDA)
- European Commission (EC) (correct)
- Centers for Disease Control and Prevention (CDC)
How many classes does the European Commission classify IVDs into based on their risk?
How many classes does the European Commission classify IVDs into based on their risk?
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Which class of IVDs requires the most regulatory oversight in the United States?
Which class of IVDs requires the most regulatory oversight in the United States?
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Which department works to ensure compliance with all IVD requirements for Agilent products?
Which department works to ensure compliance with all IVD requirements for Agilent products?
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What is the main responsibility of Medical Device Regulatory Affairs (RA) in relation to Agilent products?
What is the main responsibility of Medical Device Regulatory Affairs (RA) in relation to Agilent products?
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Who does Medical Device Regulatory Affairs (RA) work with to develop and market Agilent products?
Who does Medical Device Regulatory Affairs (RA) work with to develop and market Agilent products?
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