RAC-US Exam Training Practice Tests (RAPS Regulatory Affairs Certification (RAC) US)]

Question 1

A regulatory authority announces an inspection of a regulatory affairs professional's facility during a holiday season when most of the staff Is not available. What is the MOST practical approach to this dilemma?

A. Insist that key personnel be available for the inspection. B. Negotiate with colleagues and the authority to find a better time. C. Arrange for an inspection without all intended personnel. D. Inform the authority that the time is not suitable and request a new time

Correct Answer: B

Question 2

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?

A. Request a meeting with the regulatory authority to discuss the application. B. Review the regulatory guidelines to determine how to proceed. C. Consult with the legal department to discuss the best course of action. D. Notify the regulatory authority regarding Its obligation to honor the commitment to approve the application.

Correct Answer: A

Question 3

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 4

A regulatory affairs professional is asked to review and update regulatory affairs SOPs.
Which aspect of the SOP Is MOST important to consider?

A. Expiration date B. Revision history C. Relevance to regulations D. Scope and level of detail

Correct Answer: C

Question 5

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

A. Early technical design and product release B. Concept development and validation C. Product release and validation D. Concept development and early technical design

Correct Answer: D

Question 6

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

A. Class D B. Class A C. Class B D. Class C

Correct Answer: D

Question 7

A company is developing a new product for the global market. A new international guideline will recommend relevant studies in the pediatric population, and the guideline will be effective before the approval of the company's new product.
What is the BEST advice the regulatory affairs professional can provide to minimize the impact of this guideline on the successful registration of the new product?

A. The company should consult with relevant regulatory authorities to determine the potential impact on the current registration plan. B. The new guideline has no impact on the current registration plan, but the company must be prepared to defend its decision. C. The company should initiate the required pediatric studies immediately to avoid costly delays to the current registration plan. D. The new guideline has no impact on the current registration plan since all relevant registration studies are almost completed.

Correct Answer: A

Question 8

During face-to-face meetings with the regulatory authority to address submission issues, what is the BEST choice for the number of company representatives who should attend?

A. All senior management from the main office B. As many as required by international standards C. The minimum number of attendees necessary to address the issues D. As many as government attendees

Correct Answer: C

Question 9

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

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

Correct Answer: D

Question 10

In a distribution contract for high-risk medical devices, which of the following regulatory requirements is the MOST important for the distributor?

A. Training program for sales people B. Written procedure for product traceability C. Service operation procedures D. Local reimbursement requirements

Correct Answer: A

RAPS Regulatory Affairs Certification (RAC) US - RAC-US Exam Practice Test