RAC Regulatory Affairs Certification Exam

Question 1

A manufacturer becomes aware that a series of malfunctions with its infusion pump necessitates a nationwide field correction to prevent an unreasonable risk of substantial public harm. The company also has information reasonably suggesting these malfunctions may have contributed to a patient's death. According to 21 CFR 803, what is the mandatory reporting timeframe to the FDA for this event?

30 calendar days after becoming aware of the event. 10 working days after initiating the field correction. 5 working days after becoming aware that a reportable event requires remedial action. Within 24 hours via a phone call to the district office.

Correct Answer:

5 working days after becoming aware that a reportable event requires remedial action.

Question 2

Under the EU Medical Device Regulation (MDR 2017/745), which of the following BEST describes the purpose of the Post-Market Surveillance Report (PMSR)?

To provide a comprehensive summary of clinical investigation results for CE marking renewal. To fulfill marketing authorization requirements for the European Medicines Agency (EMA). To report all individual serious incidents to the competent authorities within 15 days. To summarize the results and conclusions of post-market surveillance data analysis primarily for Class I devices.

Correct Answer:

To summarize the results and conclusions of post-market surveillance data analysis primarily for Class I devices.

Question 3

A pharmaceutical company holds an approved New Drug Application (NDA). Which of the following is considered an "unexpected" adverse drug experience that would require an expedited 15-day "Alert Report" to the FDA?

An adverse event that is listed in the current product labeling, but is now occurring with greater severity. A serious adverse event that is already well-documented in the Investigator's Brochure from the clinical trial phase. A non-serious adverse event observed for the first time in a postmarketing study. A mild headache, which is listed as a common side effect in the product's core safety information.

Correct Answer:

An adverse event that is listed in the current product labeling, but is now occurring with greater severity.

Question 4

A medical device manufacturer identifies a software anomaly in its patient monitoring system that may, in rare circumstances, cause a temporary, 5-second data lag. This could theoretically lead to a brief delay in clinical intervention. The manufacturer initiates a voluntary correction. How would the FDA MOST likely classify this recall?

Class I Class II Class III Market Withdrawal

Correct Answer:

Class II

Question 5

The FDA has ordered a manufacturer to conduct a postmarket surveillance study under Section 522 of the FD&C Act for its permanently implantable device. This mandatory study is MOST likely intended to answer a specific question about the device's:

marketing and promotional material accuracy. long-term performance and safety. manufacturing cost-effectiveness. compliance with international standards.

Correct Answer:

long-term performance and safety.

Question 1

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About this Exam

Prepare with the RAC Regulatory Affairs Certification Exam practice quiz. This question bank includes 100 questions covering device, medical, clinical, company, and manufacturer. Use it to review important concepts, identify knowledge gaps, and build confidence for the related exam, course, or assessment.

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RAC Regulatory Affairs Certification Exam

This practice set contains 100 questions from the matching question bank and focuses on device, medical, clinical, company, and manufacturer. Work through each question carefully, review the provided solutions, and revisit topics that need more study before your next attempt.

This is an independent study resource intended for practice and review; it is not an official examination or an endorsement by any organization named in the title.

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RAC Regulatory Affairs Certification Exam

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