RAC Postmarket Surveillance and Compliance 2

Question 1

Under 21 CFR Part 803, what is the timeframe for submitting a Medical Device Report (MDR) for a death or serious injury caused by a device?

Accepted Answer

10 calendar days

Answer

Manufacturers must submit MDRs for deaths or serious injuries within 30 calendar days of becoming aware of the event.

Question 2

A manufacturer receives a complaint that a device malfunctioned but caused no injury. Under MDR regulations, when must this be reported to FDA?

Accepted Answer

30 calendar days

Answer

Malfunctions that could cause or contribute to a serious injury if they were to recur must be reported within 30 calendar days.

Question 3

Which of the following is the primary EU regulation governing postmarket surveillance for medical devices?

Accepted Answer

Regulation (EU) 2017/745 (MDR)

Answer

EU Regulation 2017/745 (MDR) is the primary regulation governing medical device postmarket surveillance in the EU, replacing MDD.

Question 4

What does a Periodic Safety Update Report (PSUR) under EU MDR require for Class IIb devices?

Accepted Answer

Submission every 2 years

Answer

Under EU MDR, PSURs for Class IIb devices must be submitted to the Notified Body every 2 years.

Question 5

In the context of postmarket surveillance, what is a 'Field Safety Corrective Action' (FSCA)?

Accepted Answer

An action taken to reduce risk of death or serious injury from a device already on the market

Answer

An FSCA is any action taken by a manufacturer to reduce risk of death or serious injury associated with a device already in distribution or use.

(RAC) Regulatory Affairs Certification Practice Test