RAC Post-Market Surveillance 3

Question 1

Under EU MDR 2017/745, what is a 'Field Safety Corrective Action' (FSCA)?

Accepted Answer

An action taken to reduce risk of death or serious deterioration in health associated with a device already on the market

Answer

An FSCA is any action taken to reduce a risk of death or serious deterioration related to a device in use, and must be reported to competent authorities.

Question 2

Which metric is MOST useful for quantifying the real-world safety signal in post-market surveillance data?

Accepted Answer

Complaint rate per units distributed

Answer

Expressing complaints as a rate per units distributed normalizes the data, allowing meaningful comparison across time periods and product versions.

Question 3

Under 21 CFR Part 803, a device manufacturer must report a device-related death within how many calendar days of becoming aware?

Accepted Answer

30 days

Answer

Manufacturers must submit an MDR for deaths and serious injuries within 30 calendar days of becoming aware, or 5 days if an immediate hazard is identified.

Question 4

Which of the following is a proactive PMS data source, as distinguished from a reactive one?

Accepted Answer

Literature surveillance reviewing published clinical studies

Answer

Literature surveillance is proactive because it monitors published evidence regardless of whether an adverse event has already occurred with the manufacturer's specific device.

Question 5

A company receives a complaint that a sterile device's packaging was found breached upon receipt. What PMS action is MOST critical to initiate first?

Accepted Answer

Assess the complaint for MDR reportability and initiate a CAPA investigation

Answer

Packaging integrity failures affecting sterility are potential MDRs and require formal CAPA investigation to determine root cause and prevent recurrence.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Post-Market Surveillance 3