FREE RAC Postmarket Surveillance and Compliance Questions and Answers

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?

Accepted Answer

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

Answer

30 calendar days after becoming aware of the event.

Answer

10 working days after initiating the field correction.

Answer

Within 24 hours via a phone call to the district office.

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)?

Accepted Answer

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

Answer

To provide a comprehensive summary of clinical investigation results for CE marking renewal.

Answer

To fulfill marketing authorization requirements for the European Medicines Agency (EMA).

Answer

To report all individual serious incidents to the competent authorities within 15 days.

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?

Accepted Answer

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

Answer

A serious adverse event that is already well-documented in the Investigator's Brochure from the clinical trial phase.

Answer

A non-serious adverse event observed for the first time in a postmarketing study.

Answer

A mild headache, which is listed as a common side effect in the product's core safety information.

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?

Accepted Answer

Class II

Answer

Class I

Answer

Class III

Answer

Market Withdrawal

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:

Accepted Answer

long-term performance and safety.

Answer

marketing and promotional material accuracy.

Answer

manufacturing cost-effectiveness.

Answer

compliance with international standards.

Question 6

A pharmaceutical company's call center receives a communication from a patient who states, "I felt dizzy after starting your new heart medication," but provides no further details. According to 21 CFR 211.198 (Complaint files), what is the MOST appropriate initial action?

Accepted Answer

Log the communication as a complaint and initiate a review or investigation according to written procedures.

Answer

Immediately file a 15-day Alert Report to the FDA based on the information received.

Answer

Wait for a healthcare professional to confirm the event before taking any action.

Answer

Discard the communication as it lacks sufficient detail and confirmation to be a valid complaint.