Free Access RAPS.RAC-US.v2023-04-24.q35 Practice Test (Page 6)

Question 21

After submission to the regulatory authority, a substantial error was found in the application. In order to resolve this issue, what should be done FIRST?

A.Resubmit the entire package.

B.Inform upper management immediately.

C.Verify the procedure in the regulation for the corrections.

D.Contact the legal department and ask them how to proceed.

Question 22

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

A.Deficiency of a device found by the user prior to patient use

B.Malfunction occurring before the end of service life of the medical device

C.Adverse event caused by patient conditions

D.Malfunction protection operated correctly

Question 23

SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

A.Inadequate training

B.Causes of non-conformities

C.Adverse environmental impacts

D.Late and/or incorrect deliverables

Question 24

What is the BEST approach to ensure that raw materials, services, and sub-contractors at the level of the vendors comply with GMP requirements?

A.Request an inspection from a regulatory authority.

B.Document and perform audits.

C.Request documentation from the sub-contractor.

D.Ask the vendor to take responsibility.

Question 25

A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?

A.Promote off-label use to a carefully selected patient population.

B.Delay product launch until required studies are completed.

C.Label the product for use in appropriate populations.

D.Educate patients and healthcare providers on how to use the product

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