RAC Postmarket Surveillance and Compliance 3

Question 1

Which FDA database is the primary public repository for adverse event reports related to medical devices?

Accepted Answer

MAUDE (Manufacturer and User Facility Device Experience)

Answer

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?

Accepted Answer

Both the manufacturer and the hospital as a user facility

Answer

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?

Accepted Answer

Class I involves reasonable probability of serious health consequences; Class II involves temporary or reversible adverse health consequences

Answer

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?

Accepted Answer

2 days

Answer

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?

Accepted Answer

The malfunction would likely cause or contribute to serious injury if it recurred

Answer

A malfunction is MDR-reportable if it would likely cause or contribute to serious injury or death if it were to recur.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Postmarket Surveillance and Compliance 3