Get Sep-2025 updated RAC-US Certification Exam Sample Questions [Q55-Q78]

QUESTION 55
Which analysis method is MOST appropriate to prioritize risk and monitor the effectiveness of risk control activities for a medical device?

QUESTION 56
Which of the following situations does NOT require rapid communication to regulatory authorities?

QUESTION 57
SOPs for preventive and corrective actions MUST include the procedure to eliminate which of the following?

QUESTION 58
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?

QUESTION 59
As a member of the product launch review committee, a regulatory affairs professional discovers a major issue with the labeling of a product prior to production. In addition to informing the committee, which is the BEST approach to address the issue?

QUESTION 60
A global company is developing a sophisticated implantable medical device that is coated with antibiotics and biologics to enhance its efficacy.
The product is marketed in Country X.
where it is regulated as a medical device.
The same product, without the antibiotics and biologics, is marketed as a medical device in Country Y.
The company is proposing to start marketing the coated device in Country Y.
Which regulatory approach should the company propose?

QUESTION 61
A protocol for a pivotal registration trial of a new product is submitted to a major regulatory authority for review and approval. The regulatory authority issues the company a written commitment that if the studies are completed as outlined in the protocol and the results meet the pre-specified criteria for efficacy and safety, the product will be approved.
During the final week of the review of the marketing application, which has fully met all pre- specified criteria, the company receives a letter from the regulatory authority stating that it no longer believes that the product will be approved based on a recent withdrawal of a similar product in another country.
What is the BEST response?

QUESTION 62
A regulation change is imminent and may require further non-clinical testing on a product currently in Phase III clinical trials. What is the most appropriate action to take FIRST?

QUESTION 63
During an audit of a contract manufacturing facility by a potential client, the auditor requested to be left alone in the records room. The records room contains information on all products produced by the contract manufacturer.
Which action is MOST appropriate for the regulatory affairs professional to take?

QUESTION 64
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?

QUESTION 65
A clinical study of a drug is completed to support a marketing approval application.
According to ICH, how long should a sponsor retain the clinical study essential documents?

QUESTION 66
The requirements for document control are located in which of the following documents?

QUESTION 67
Following the introduction of a new regulation, an evaluation of the company’s products by the regulatory affairs professional indicates that 60 percent do not comply with the regulation.
What should the regulatory affairs professional do FIRST to meet the new requirement?

QUESTION 68
Company X encounters challenges in the global life cycle management of its medical devices. Which of the following Is MOST appropriate for improving product life cycle management?

QUESTION 69
A superiority advertising claim for a product versus its competitor’s product can only be made under which of the following circumstances?

QUESTION 70
Who has the PRIMARY responsibility for recall of products with quality defects?

QUESTION 71
What is the LAST stage in the development of a quality risk management process for a medical device?

QUESTION 72
A materials supplier informs a company that it intends to stop supplying a material critical to the manufacture of the company’s products. What action should the company take FIRST?

QUESTION 73
Which of the following is the BEST approach for mitigating potential regulatory compliance issues at your company?

QUESTION 74
Which of the following is the PRIMARY purpose of an audit report?

QUESTION 75
In preparation for the development of a new line of products, a regulatory affairs professional is asked to prepare a short presentation for senior management. Which of the following topics is MOST important to cover?

QUESTION 76
According to ICH, which of the following components of study information is NOT required in a clinical study report?

QUESTION 77
Company X and Company Y both have products for the treatment of rare genetic diseases.
Company X would like to acquire Company Y but does not know enough about Company Y to make an offer.
What is the MOST appropriate approach that Company X should take to acquire more information about Company Y?

QUESTION 78
A process is ultimately validated to ensure which of the following?