Post-Market Surveillance Flashcards
7 cards from real RAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Post-Market Surveillance flashcards as text
Under EU MDR 2017/745, what is a 'Field Safety Corrective Action' (FSCA)?
Answer: An action taken to reduce risk of death or serious deterioration in health associated with a device already on the market
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.
Which metric is MOST useful for quantifying the real-world safety signal in post-market surveillance data?
Answer: Complaint rate per units distributed
Expressing complaints as a rate per units distributed normalizes the data, allowing meaningful comparison across time periods and product versions.
Under 21 CFR Part 803, a device manufacturer must report a device-related death within how many calendar days of becoming aware?
Answer: 30 days
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.
Which of the following is a proactive PMS data source, as distinguished from a reactive one?
Answer: Literature surveillance reviewing published clinical studies
Literature surveillance is proactive because it monitors published evidence regardless of whether an adverse event has already occurred with the manufacturer's specific device.
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?
Answer: Assess the complaint for MDR reportability and initiate a CAPA investigation
Packaging integrity failures affecting sterility are potential MDRs and require formal CAPA investigation to determine root cause and prevent recurrence.
What distinguishes a Post-Market Surveillance Report (PMSR) from a Periodic Safety Update Report (PSUR) under EU MDR?
Answer: PMSRs are for Class I devices only; PSURs are required for Class IIa, IIb, and III
Under EU MDR Articles 85 and 86, Class I devices need a PMSR while Class IIa, IIb, and III devices require the more comprehensive PSUR.
In the context of PMS complaint handling, what does 'MDR decisioning' require the manufacturer to document?
Answer: The rationale for why a complaint does or does not meet MDR reporting criteria
FDA expects written documentation of the analysis and justification used to determine whether each complaint meets MDR reportability thresholds.