RAC Postmarket Surveillance and Compliance 3 — Questions and Answers
Question 1: Which FDA database is the primary public repository for adverse event reports related to medical devices?
- FAERS (FDA Adverse Event Reporting System)
- MAUDE (Manufacturer and User Facility Device Experience) (Correct answer)
- VAERS (Vaccine Adverse Event Reporting System)
- SENTINEL (Active Surveillance System)
Correct answer: MAUDE (Manufacturer and User Facility Device Experience)
MAUDE is FDA's primary public database for medical device adverse event reports submitted by manufacturers, importers, and device user facilities.
Question 2: A hospital's biomedical engineering department discovers that a ventilator's alarm failed to alert staff, contributing to a patient death. Under MDR regulations, who must report this event to FDA?
- Only the device manufacturer
- Only the hospital as a user facility
- Both the manufacturer and the hospital as a user facility (Correct answer)
- Only the attending physician
Correct answer: Both the manufacturer and the hospital as a user facility
Both device manufacturers and user facilities (hospitals) have independent MDR reporting obligations for deaths caused by or suspected to be caused by devices.
Question 3: What is the primary distinction between a Class I recall and a Class II recall under FDA's recall classification system?
- Class I involves drugs; Class II involves devices
- Class I involves reasonable probability of serious health consequences; Class II involves temporary or reversible adverse health consequences (Correct answer)
- Class I is voluntary; Class II is mandatory
- Class I applies to manufacturers; Class II applies to distributors
Correct answer: Class I involves reasonable probability of serious health consequences; Class II involves temporary or reversible adverse health consequences
Class I recalls involve products where use or exposure may cause serious adverse health consequences or death; Class II involves temporary or medically reversible effects.
Question 4: Under EU MDR Article 87, serious incidents must be reported to competent authorities within what timeframe for incidents involving an immediate risk to public health?
- 2 days (Correct answer)
- 7 days
- 15 days
- 30 days
Correct answer: 2 days
Under EU MDR, serious incidents posing an immediate risk to public health must be reported to competent authorities within 2 days.
Question 5: A regulatory affairs professional is reviewing a complaint that could qualify as an MDR-reportable event. Which criterion makes a malfunction MDR-reportable even without causing an injury?
- The malfunction occurred during the warranty period
- The malfunction would likely cause or contribute to serious injury if it recurred (Correct answer)
- The device was used off-label at the time of malfunction
- The malfunction was reported by more than one user
Correct answer: The malfunction would likely cause or contribute to serious injury if it recurred
A malfunction is MDR-reportable if it would likely cause or contribute to serious injury or death if it were to recur.
Question 6: In postmarket surveillance planning, what does the term 'signal detection' refer to?
- Electronic monitoring of wireless device transmissions
- Identifying new or changing safety issues from PMS data sources such as complaints, literature, and registries (Correct answer)
- Detecting counterfeit devices in the supply chain
- Monitoring competitor product performance data
Correct answer: Identifying new or changing safety issues from PMS data sources such as complaints, literature, and registries
Signal detection involves systematically analyzing PMS data to identify previously unknown or underrecognized safety risks associated with a device.
Question 7: Which document in a device's technical file summarizes conclusions from postmarket surveillance data and updates the benefit-risk determination?
- Post-Market Clinical Follow-up (PMCF) Plan
- Post-Market Surveillance Report (PMSR)
- Periodic Safety Update Report (PSUR) (Correct answer)
- Summary of Safety and Clinical Performance (SSCP)
Correct answer: Periodic Safety Update Report (PSUR)
The PSUR synthesizes PMS data findings and updates the benefit-risk determination for the device on a periodic basis.
RAC Postmarket Surveillance and Compliance 3
Which FDA database is the primary public repository for adverse event reports related to medical devices?