QUESTION: 13

According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to report an adverse event?

Deficiency of a device found by the user prior to patient use
Adverse event caused by patient conditions
Malfunction occurring before the end of service life of the medical device
Malfunction protection operated correctly

Answer(s): B,C

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QUESTION: 14

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?

Approved indications of the drug
Determination of primary mode of action
Determination of product design deliverables
Guidance documents for the device

Answer(s): C

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During a regulatory authority inspection of a manufacturing site, the inspector observes that one of the medicinal products manufactured at the site is not GMP compliant. The product Is distributed globally.
Which of the following is the most appropriate action to take FIRST?

Withdraw the affected product from the markets.
Send a "Dear Dr." letter to customers.
Notify the global regulatory authorities.
Assess the potential safety risk.

Answer(s): C

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QUESTION: 16

Company X and Company Y both have products for the treatment of rare genetic diseases. Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.

What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?

Enter into an agreement with Company Y to perform due diligence.
Recruit a professional to gather confidential intelligence on Company Y.
Request the needed information from the Board of Directors of Company Y.
Perform a thorough library search to gather detailed information on Company Y.

Answer(s): A

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QUESTION: 13

QUESTION: 14

QUESTION: 15

QUESTION: 16