RAPS Regulatory Affairs Certification (RAC) US - RAC-US Exam Questions [2026]

QUESTION NO: 1
According to ISO 14971, what is the FIRST step when developing a risk management plan for a medical device?

A. Risk control B. Risk management C. Risk analysis D. Risk estimation

Correct Answer: C

QUESTION NO: 2
Which of the following claims would classify an apple as a drug?

A. "It will prevent colds." B. "It will whiten teeth." C. "It will make you look younger." D. "It will satisfy hunger."

Correct Answer: A

QUESTION NO: 3
The regulatory authority contacts the regulatory affairs professional regarding a complaint about a drug produced by the company. A consumer reported to the regulatory authority that the tablets have a slightly different color and break easily.
Which of the following actions should the regulatory affairs professional take?

A. Ask that the regulatory authority provide the batch number printed on the packaging of the affected product. B. Respond to the regulatory authority that the company will provide copies of the relevant
QC records for batch release. C. Respond to the regulatory authority that the product subject to the complaint is most likely a counterfeit product. D. Ask that the regulatory authority provide the actual product subject to the complaint.

Correct Answer: A

QUESTION NO: 4
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?

A. Add a warning in the IFU. B. Perform another risk-benefit analysis. C. Discontinue the project. D. Redesign the device.

Correct Answer: D

QUESTION NO: 5
Who has the PRIMARY responsibility for recall of products with quality defects?

A. Regulatory authority B. Consumer C. Distributor D. Manufacturer

Correct Answer: D

QUESTION NO: 6
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. Request a permanent waiver from the new regulation. C. Contact the trade association for advice. D. Communicate with the relevant internal departments.

Correct Answer: D

QUESTION NO: 7
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?

A. Consult with the company's legal department regarding options. B. Obtain a copy of the proposed regulation and analyze the impact. C. Inform the company's senior management and arrange an emergency meeting D. Arrange for additional testing of the product at the testing facility.

Correct Answer: B

QUESTION NO: 8
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 both identification and non-clinical qualification studies concurrently. B. Perform an identification study, wait until the result is available, and then consider performing a non-clinical qualification study. C. Perform a non-clinical qualification study, wait until the result is available, and then consider performing an identification study. D. Perform either an identification study or a non-clinical qualification study.

Correct Answer: B

QUESTION NO: 9
Company X has a patent for an anti-inflammatory drug that will expire in one year. In order to minimize the effect of the patent expiration, which is the BEST action for the company to take?

A. Explore litigation strategy for patent infringements on the drug. B. Develop a generic version of the drug. C. Develop a better brand-name drug in the same class. D. Conduct a Phase III study for a new unrelated indication of the drug.

Correct Answer: B

QUESTION NO: 10
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. Specification B. Property C. Formulation D. Justification

Correct Answer: D