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NEW QUESTION 27
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

A. Class CB. Class DC. Class AD. Class B

Answer: A

 

NEW QUESTION 28
A company is developing a device-drug combination product. Which of the following should be evaluated FIRST in order to determine the applicable guidance documents?

A. Determination of primary mode of actionB. Determination of product design deliverablesC. Approved indications of the drugD. Guidance documents for the device

Answer: B

 

NEW QUESTION 29
The requirements for document control are located in which of the following documents?

A. IEC 60601B. WHO guidelinesC. ISO 13485D. ICH guidelines

Answer: C

 

NEW QUESTION 30
Why is it necessary to run supplemental safety pharmacology studies?

A. To provide adverse reaction reports and the results of the statistical data to the regulatory authorityB. To evaluate potential adverse pharmacodynamics effects not addressed by the core batteryC. To substitute the utilization of GLPD. To comply with regulatory authority requirements related to clinical studies

Answer: B

 

NEW QUESTION 31
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