QUESTION: 33

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

Class A
Class B
Class C
Class D

Answer(s): C

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QUESTION: 34

A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

In vitro studies show the product to be superior.
Government survey data indicate the product is superior.
Results of a three-year, post-market patient survey indicate the product is superior.
Results of adequate, well-controlled comparative clinical trial show the product is superior.

Answer(s): D

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QUESTION: 35

A company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

Concept development and validation
Concept development and early technical design
Early technical design and product release
Product release and validation

Answer(s): B

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QUESTION: 36

Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?

Before the enactment of the regulation, through the industry representative
Before the enactment of the regulation, through formal comments gathering process
After the enactment of the regulation, through the industry representative
After the enactment of the regulation, through a product-specific meeting

Answer(s): B

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QUESTION: 33

QUESTION: 34

QUESTION: 35

QUESTION: 36