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NEW QUESTION 32
According to the GHTF, which of the following is NOT an exemption rule when evaluating the decision to
report an adverse event?

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

Answer: C

 

NEW QUESTION 33
Under which of the following circumstances would a regulatory authority require a more detailed
premarket submission, a more rigorous audit, and/or the provision of more performance evaluation data
than would normally apply to an IVD device of that risk class?

  • A. The device incorporates well-established technology that is already present in the market.
  • B. The device is an updated version of a compliant device from the same manufacturer and contains no
    substantive change.
  • C. Internationally recognized standards are available to cover the main aspects of the device and have
    been used by the manufacturer.
  • D. The manufacturer’s experience level with the type of IVD medical device is limited.

Answer: D

 

NEW QUESTION 34
The API used for an approved drug product conforms to international monograph specifications and local
pharmacopeia; however, the international monograph specifications of the API will be changing soon.
Which is the most appropriate action for the regulatory affairs professional to take FIRST?

  • A. Analyze the impact of the international monograph change on the local pharmacopeia.
  • B. Confirm that the international monograph change is not related to local pharmacopeia.
  • C. Transfer the notice of the upcoming international monograph change to QA for further processing.
  • D. Prepare the international monograph change submission first and then prepare the local change when
    required.

Answer: C

 

NEW QUESTION 35
An inspection of a manufacturing site determines that a number of manufacturing changes have been
implemented without obtaining the necessary regulatory clearance. Which of the following actions should
the regulatory affairs professional complete FIRST?

  • A. Review the stability data for the changes.
  • B. Stop product manufacturing.
  • C. Establish validation procedures.
  • D. Assess the impact of the changes.

Answer: B

 

NEW QUESTION 36
Which term does NOT describe the same concept as the others?

  • A. Subsequent entry biologics
  • B. Monoclonal antibody
  • C. Biosimilars
  • D. Follow-on protein products

Answer: B

 

NEW QUESTION 37
……

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