RAC Post-Market Surveillance 2

Question 1

Under FDA regulations, which event involving a marketed device MUST be reported on a MedWatch 3500A form within 30 days?

Accepted Answer

A device malfunction that could cause serious injury if it recurs

Answer

A customer complaint about device packaging aesthetics

Answer

A software update that adds a new non-safety feature

Answer

A voluntary field correction with no associated injuries

Question 2

What is the primary purpose of a Post-Market Clinical Follow-Up (PMCF) study for a medical device?

Accepted Answer

To collect additional clinical data confirming safety and performance in real-world use

Answer

To satisfy FDA's Investigational Device Exemption requirements

Answer

To generate marketing materials for device promotion

Answer

To replace the need for a pre-market clinical investigation

Question 3

Which FDA database is the PRIMARY source manufacturers must search when evaluating complaints for potential MDR reportability?

Accepted Answer

MAUDE (Manufacturer and User Facility Device Experience)

Answer

FDA FAERS (Adverse Event Reporting System)

Answer

DailyMed

Answer

FDA 510(k) Premarket Notification database

Question 4

A distributor receives a serious injury complaint for a device manufactured by a third party. Under 21 CFR Part 803, who bears the primary MDR reporting obligation?

Accepted Answer

The device manufacturer

Answer

The distributor, because they placed the product in commerce

Answer

Both the distributor and manufacturer equally

Answer

The end user who experienced the injury

Question 5

Which EU MDR 2017/745 document must be updated at least every 5 years (for Class III devices, more frequently) and summarize the PMS conclusions?

Accepted Answer

Periodic Safety Update Report (PSUR)

Answer

Summary of Safety and Clinical Performance (SSCP)

Answer

Declaration of Conformity

Answer

Technical Documentation

Question 6

In a risk management context, how should new post-market safety information that reveals an unacceptable risk-benefit ratio be handled?

Accepted Answer

Feed it back into the risk management file and reassess risk controls

Answer

Archive the information and await the next scheduled design review

Answer

Issue a press release to notify the public directly

Answer

Immediately withdraw the device without regulatory notification

Question 7

A manufacturer identifies through PMS that a device component is failing at a rate higher than predicted in the design phase. What is the MOST appropriate immediate next step?

Accepted Answer

Conduct a root cause analysis and assess whether a CAPA or field action is needed

Answer

Continue selling the current inventory while redesigning the next version

Answer

Notify the FDA only after 30 days have passed

Answer

Remove the device from the market without notifying competent authorities