Prepare for your exam certification with our RAC-US Certified RAPS
Free RAPS RAC-US Exam 2026 Practice Materials Collection
The RAC-US exam is intended for regulatory affairs professionals who are looking to advance their careers and demonstrate their expertise in the field. RAC-US exam is open to individuals who have at least five years of experience in regulatory affairs, as well as those who have completed a graduate degree in regulatory affairs or a related field. The RAC-US exam is recognized internationally as a mark of excellence in regulatory affairs, and it is often required or preferred by employers in the industry.
NEW QUESTION # 41
According to the GHTF IVD guidance, which of the following is the CORRECT classification for a blood glucose self-testing kit?
- A. Class A
- B. Class D
- C. Class C
- D. Class B
Answer: C
NEW QUESTION # 42
A manufacturer is involved in a recall event process for a plasma-derived product. From which stage should the manufacturer be able to trace back the product?
- A. Plasma pooling
- B. Individual plasma donation
- C. Product distribution
- D. Plasma fractionation
Answer: C
NEW QUESTION # 43
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?
- A. Submit the product as a medical device in Country Y as the product is already marketed in Country X as a medical device.
- B. Examine decisions made about similar products in Country Y to propose the classification of the product.
- C. Submit the product for review as a pharmaceutical product in Country Y.
- D. Apply for review of the additional part of the product as a pharmaceutical product in Country
Answer: D
NEW QUESTION # 44
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?
- A. Deny the auditor access to the room and records due to confidentiality concerns.
- B. Allow the auditor access to the room and records due to the current audit.
- C. Allow the auditor accompanied access to the room to retrieve the records.
- D. Deny the auditor access to the room and retrieve only the requested records.
Answer: C
NEW QUESTION # 45
According to ICH, which of the following components of study information is NOT required in a clinical study report?
- A. Protocol and protocol amendments
- B. Randomization scheme and codes
- C. Detailed CV of all investigators
- D. List of lECs or lRBs
Answer: C
NEW QUESTION # 46
A drug product presents degradation during the manufacturing process. In addition to the amount, what information should be provided FIRST in order to use API overage?
- A. Property
- B. Formulation
- C. Justification
- D. Specification
Answer: C
NEW QUESTION # 47
In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?
- A. Written procedure for product traceability
- B. Training program for sales people
- C. Local reimbursement requirements
- D. Service operation procedures
Answer: B
NEW QUESTION # 48
At a recent scientific meeting, Company Y had two booths:
* At one booth, Company Y provided brochures on a completed Phase II study.
* In an adjacent booth, Company Y's sales professionals were promoting one of Company
Y's marketed products.
A regulatory affairs-professional at Company X sends a letter to a counterpart at Company
Y requesting that Company Y stop this practice in the future and demanding a formal response to the letter. How should the regulatory affairs professional at Company Y BEST respond?
- A. Inform the local regulatory authority of the letter and discuss how to respond.
- B. Inform Company X that it has no right to send such a letter and do nothing further.
- C. Acknowledge receipt of the letter in a written response but do nothing further.
- D. Inform the legal department of the letter and discuss how to respond.
Answer: D
NEW QUESTION # 49
A company establishes a new medical device indication for its consumer disposable products. The regulatory affairs professional is asked to give a 30-minute training session on these products to sales representatives. Which of the following subjects is the MOST important to discuss?
- A. Safety-related reporting
- B. Regulatory application summary
- C. Risk management process
- D. Labeling
Answer: D
NEW QUESTION # 50
When applying for marketing approval of a drug for a rare disease, which requirement can be waived?
- A. Phase I and II clinical trials
- B. Phase I clinical trials
- C. Pre-clinical studies
- D. Phase III clinical trials
Answer: D
NEW QUESTION # 51
During new drug development, a new impurity in the drug substance is detected at a level of 0.12%. The intended maximum daily dose Is less than 2 g/day, and the drug Is known generally not to be toxic.
What should be done in response to identifying the impurity?
- A. Perform either an identification study or a non-clinical qualification study.
- B. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study.
- C. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study.
- D. Perform both identification and non-clinical qualification studies concurrently.
Answer: C
NEW QUESTION # 52
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?
- A. Prepare documents for the files.
- B. Contact the trade association for advice.
- C. Communicate with the relevant internal departments.
- D. Request a permanent waiver from the new regulation.
Answer: C
NEW QUESTION # 53
The regulatory authority in Country X issued a request for a mandatory product recall in
Country X due to serious injuries to patients. This product also is distributed in Country Y.
What should the regulatory affairs professional of the product's manufacturer FIRST do in
Country Y?
- A. Review alt distribution records and complaints reported in Country Y.
- B. Initiate a mandatory recall of the product in Country Y.
- C. Prepare the legal team in Country Y for possible litigations.
- D. Draft a formal letter to customers in Country Y about this recall.
Answer: A
NEW QUESTION # 54
As part of the regulatory strategy for companies intending to manufacture a psychotropic product, which of the following approvals should be received FIRST?
- A. Site license
- B. Export license
- C. Import license
- D. Product license
Answer: A
NEW QUESTION # 55
In the process of obtaining a product approval, a regulatory affairs professional discovers that the product does not meet one of the specific technical requirements of the regulation.
However, competitors with substantially similar products have claimed compliance with the requirement and received approval. Which action should the regulatory affairs professional take FIRST?
- A. Inform the regulatory authority that such a requirement is not applicable to the product.
- B. Notify senior management that the product cannot be registered.
- C. Inform the internal departments to redesign the product to comply with this requirement.
- D. Discuss with the regulatory apriority and attempt to reach an acceptable solution.
Answer: D
NEW QUESTION # 56
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. Adverse event caused by patient conditions
- C. Deficiency of a device found by the user prior to patient use
- D. Malfunction occurring before the end of service life of the medical device
Answer: B
NEW QUESTION # 57
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?
- A. Capacity of the manufacturing facilities to fully produce the new product
- B. Previous actions taken by regulatory authorities on similar products
- C. Regulatory requirements for labeling and packaging
- D. Potential clinical sites for the Phase III clinical trial
Answer: B
NEW QUESTION # 58
Which of the following is the MOST desirable timing and approach for a regulatory affairs professional who wants to provide feedback on proposed new regulations?
- A. After the enactment of the regulation, through a product-specific meeting
- B. After the enactment of the regulation, through the industry representative
- C. Before the enactment of the regulation, through formal comments gathering process
- D. Before the enactment of the regulation, through the industry representative
Answer: C
NEW QUESTION # 59
Which of the following statements regarding the off-label use of drugs is CORRECT?
- A. Sponsors are allowed to distribute publications about unapproved uses of approved drugs and devices as long as the marketing application is under review by the regulatory authority.
- B. Although the regulatory authority reviews and approves drugs for specific indications, the approval does not limit the use of those drugs in clinical practice.
- C. The peer-reviewed literature can ensure high-quality off-label promotion of medications, thereby increasing access to much needed drugs and devices.
- D. The regulatory authority does not restrict physician prescribing for off-label indications or regulate the manufacturer's promotion for such use.
Answer: B
NEW QUESTION # 60
A company's product was approved by a regulatory authority with the condition that further studies must be completed prior to full approval of the product.
To minimize product-associated risk to patients during the period of conditional approval, what is the LEAST effective way to achieve this goal?
- A. Promote off-label use to a carefully selected patient population.
- B. Educate patients and healthcare providers on how to use the product
- C. Delay product launch until required studies are completed.
- D. Label the product for use in appropriate populations.
Answer: A
NEW QUESTION # 61
......
Pass RAPS RAC-US Actual Free Exam Q&As Updated Dump: https://www.pass4suresvce.com/RAC-US-pass4sure-vce-dumps.html
RAC-US Exam Info and Free Practice Test All-in-One Exam Guide Jan-2026: https://drive.google.com/open?id=1XX9VO2NyefUhSZDtieWRmKpw3jV0w4Q4