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Free RAC-US Exam Braindumps
Regulatory Affairs Certification (RAC) US Questions 31–35 (page: 8)

Updated On: 9-Feb-2026
Page 8 of 21
PDF with 100 Questions

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?

  1. Approved indications of the drug
  2. Determination of primary mode of action
  3. Determination of product design deliverables
  4. Guidance documents for the device

Answer(s): C



Which of the following BEST describes the purpose of the ICH?

  1. To provide scientific evaluation of applications for international marketing authorization for safe, effective, and high-quality medicines for the ICH regions
  2. To protect and promote public health through the evaluation and supervision of safe, effective, and high-quality medicines for the ICH regions
  3. To lobby for improved industry standards for the development of new safe, effective, and high-quality medicines for the ICH regions
  4. To discuss and establish common guidelines for safe, effective, and high-quality medicines for the ICH regions

Answer(s): D



According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

  1. Class A
  2. Class B
  3. Class C
  4. Class D

Answer(s): C



A superiority advertising claim for a product versus its competitor's product can only be made under which of the following circumstances?

  1. In vitro studies show the product to be superior.
  2. Government survey data indicate the product is superior.
  3. Results of a three-year, post-market patient survey indicate the product is superior.
  4. Results of adequate, well-controlled comparative clinical trial show the product is superior.

Answer(s): D



A company is developing a new medical device. During which initial stage is it MOST appropriate (or a regulatory affairs professional to become involved?

  1. Concept development and validation
  2. Concept development and early technical design
  3. Early technical design and product release
  4. Product release and validation

Answer(s): B



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