RAC Post-Market Surveillance 3 — Questions and Answers
Question 1: Under EU MDR 2017/745, what is a 'Field Safety Corrective Action' (FSCA)?
- An action taken to reduce risk of death or serious deterioration in health associated with a device already on the market (Correct answer)
- A scheduled preventive maintenance activity by the manufacturer
- A recall initiated solely for commercial reasons
- An internal audit of the manufacturing process
Correct 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.
Question 2: Which metric is MOST useful for quantifying the real-world safety signal in post-market surveillance data?
- Complaint rate per units distributed (Correct answer)
- Gross revenue per product line
- Number of social media mentions
- Total units manufactured per quarter
Correct 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.
Question 3: Under 21 CFR Part 803, a device manufacturer must report a device-related death within how many calendar days of becoming aware?
- 30 days (Correct answer)
- 5 days
- 15 days
- 45 days
Correct 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.
Question 4: Which of the following is a proactive PMS data source, as distinguished from a reactive one?
- Literature surveillance reviewing published clinical studies (Correct answer)
- Customer complaint records received after a device failure
- MDRs filed following a patient injury
- Regulatory authority safety alerts issued after incidents
Correct 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.
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?
- Assess the complaint for MDR reportability and initiate a CAPA investigation (Correct answer)
- Send a replacement device immediately and close the complaint
- Instruct the customer to use the device anyway if it appears undamaged
- Wait for additional similar complaints before taking action
Correct 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.
Question 6: What distinguishes a Post-Market Surveillance Report (PMSR) from a Periodic Safety Update Report (PSUR) under EU MDR?
- PMSRs are for Class I devices only; PSURs are required for Class IIa, IIb, and III (Correct answer)
- PSURs are for Class I devices; PMSRs apply to higher-risk classes
- PMSRs and PSURs are interchangeable terms under EU MDR
- Both are required for all device classes regardless of risk
Correct 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.
Question 7: In the context of PMS complaint handling, what does 'MDR decisioning' require the manufacturer to document?
- The rationale for why a complaint does or does not meet MDR reporting criteria (Correct answer)
- The customer's satisfaction score after complaint resolution
- Marketing strategy changes resulting from the complaint
- The number of social media reposts of the complaint
Correct 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.
RAC Post-Market Surveillance 3
Under EU MDR 2017/745, what is a 'Field Safety Corrective Action' (FSCA)?