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Regulatory Agencies in the IVD Market
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Regulatory Agencies in the IVD Market

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Questions and Answers

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?

  • Six
  • Five
  • Three (correct)
  • Four

    • 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?

    <p>Four</p> Signup and view all the answers

    Which class of IVDs requires the most regulatory oversight in the United States?

    <p>Class III</p> Signup and view all the answers

    Which department works to ensure compliance with all IVD requirements for Agilent products?

    <p>Medical Device Regulatory Affairs (RA)</p> Signup and view all the answers

    What is the main responsibility of Medical Device Regulatory Affairs (RA) in relation to Agilent products?

    <p>Ensuring product safety and effectiveness</p> Signup and view all the answers

    Who does Medical Device Regulatory Affairs (RA) work with to develop and market Agilent products?

    <p>Research and Development</p> Signup and view all the answers

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