RAC Post-Market Surveillance 2 — Questions and Answers
Question 1: Under FDA regulations, which event involving a marketed device MUST be reported on a MedWatch 3500A form within 30 days?
- A device malfunction that could cause serious injury if it recurs (Correct answer)
- A customer complaint about device packaging aesthetics
- A software update that adds a new non-safety feature
- A voluntary field correction with no associated injuries
Correct answer: A device malfunction that could cause serious injury if it recurs
MDR regulations require a 30-day report for malfunctions that could cause or contribute to serious injury or death if they were to recur.
Question 2: What is the primary purpose of a Post-Market Clinical Follow-Up (PMCF) study for a medical device?
- To collect additional clinical data confirming safety and performance in real-world use (Correct answer)
- To satisfy FDA's Investigational Device Exemption requirements
- To generate marketing materials for device promotion
- To replace the need for a pre-market clinical investigation
Correct answer: To collect additional clinical data confirming safety and performance in real-world use
PMCF proactively gathers clinical evidence from post-market use to confirm ongoing safety and performance and address residual uncertainties.
Question 3: Which FDA database is the PRIMARY source manufacturers must search when evaluating complaints for potential MDR reportability?
- MAUDE (Manufacturer and User Facility Device Experience) (Correct answer)
- FDA FAERS (Adverse Event Reporting System)
- DailyMed
- FDA 510(k) Premarket Notification database
Correct answer: MAUDE (Manufacturer and User Facility Device Experience)
MAUDE contains MDRs submitted by manufacturers, importers, and device facilities, making it the primary reference for evaluating complaint trends and MDR precedents.
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?
- The device manufacturer (Correct answer)
- The distributor, because they placed the product in commerce
- Both the distributor and manufacturer equally
- The end user who experienced the injury
Correct answer: The device manufacturer
Under 21 CFR Part 803, manufacturers hold primary MDR reporting responsibility; distributors are required reporters only in specific circumstances defined in the regulation.
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?
- Periodic Safety Update Report (PSUR) (Correct answer)
- Summary of Safety and Clinical Performance (SSCP)
- Declaration of Conformity
- Technical Documentation
Correct answer: Periodic Safety Update Report (PSUR)
The PSUR, required under EU MDR Article 86, synthesizes post-market surveillance data and must be updated at defined intervals based on device risk class.
Question 6: In a risk management context, how should new post-market safety information that reveals an unacceptable risk-benefit ratio be handled?
- Feed it back into the risk management file and reassess risk controls (Correct answer)
- Archive the information and await the next scheduled design review
- Issue a press release to notify the public directly
- Immediately withdraw the device without regulatory notification
Correct answer: Feed it back into the risk management file and reassess risk controls
ISO 14971 requires that post-production information be evaluated and, if it indicates an unacceptable risk, fed back into the risk management process to update controls.
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?
- Conduct a root cause analysis and assess whether a CAPA or field action is needed (Correct answer)
- Continue selling the current inventory while redesigning the next version
- Notify the FDA only after 30 days have passed
- Remove the device from the market without notifying competent authorities
Correct answer: Conduct a root cause analysis and assess whether a CAPA or field action is needed
Discovering an unexpected failure rate requires root cause analysis and a CAPA assessment to determine if a field safety corrective action is necessary.
RAC Post-Market Surveillance 2
Under FDA regulations, which event involving a marketed device MUST be reported on a MedWatch 3500A form within 30 days?