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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
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
- 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.
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
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.
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
NEW QUESTION 37
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