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RAPS RAC-US Exam
Regulatory Affairs Certification (RAC) US (Page 3 )

Updated On: 19-Jan-2026
Page 3 of 21
PDF with 100 Questions

After numerous failed attempts to decrease an identified risk in a medical device to an acceptable level, the medical device continues to have unacceptable risks. However, the development team wants to continue development. Which is the BEST recommendation to make in this situation?

  1. Add a warning in the IFU.
  2. Discontinue the project.
  3. Perform another risk-benefit analysis.
  4. Redesign the device.

Answer(s): D



Which term does NOT describe the same concept as the others?

  1. Biosimilars
  2. Follow-on protein products
  3. Monoclonal antibody
  4. Subsequent entry biologics

Answer(s): C



A company is developing a novel drug to combat AIDS. The preliminary results are very promising and include instances of complete remission. The company has been granted patents in multiple countries for the drug. The regulatory affairs professional is asked to prepare a brief report concerning potential problems for marketing of the product worldwide. Which of the following is the MOST important consideration to discuss?

  1. Doha Declaration in the TRIPS Agreement
  2. The stability of the drug in all zone conditions
  3. The time frame in which the patent will expire
  4. International import and export regulations

Answer(s): B



A company is currently marketing an implantable orthopedic medical device. The R&D department is planning to change the material used for the implant. The R&D department states that the change does not impact the safety and effectiveness of the product.

What action should the regulatory affairs professional take FIRST?

  1. No action is needed in this situation.
  2. Prepare regulatory submissions that detail the medical device's change in materials.
  3. Review the content of change and supporting data for the equivalency with the current material.
  4. Write a memo to file since the change does not impact product safety and effectiveness.

Answer(s): C



According to the ICH guideline on GMP for API, to which of the following is the MOST stringent requirement applied?

  1. Physical processing and packaging
  2. Isolation and purification
  3. Production of Intermediate(s)
  4. Introduction of the API starting material

Answer(s): A



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