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 ISO 13485:2016, which clause specifically requires procedures for post-market surveillance activities including feedback and complaint handling?
Answer: Clause 8.2 — Monitoring and Measurement
ISO 13485:2016 Clause 8.2 covers monitoring and measurement, including customer feedback, complaint handling, and reporting to regulatory authorities.
A PMS plan should define data sources, evaluation methods, and thresholds for action. Which element is MOST critical for triggering a CAPA?
Answer: Pre-defined signal detection thresholds based on risk
Pre-defined, risk-based signal thresholds ensure that PMS data triggers corrective action objectively, before problems escalate.
Which FDA guidance describes the expectation that manufacturers maintain a vigilance system to detect, report, and correct problems with marketed devices?
Answer: FDA Guidance on Medical Device Reporting for Manufacturers
FDA's MDR guidance for manufacturers outlines the vigilance system expectations, including what constitutes a reportable event and required timelines.
When conducting trend analysis on PMS data, which statistical approach is typically used to identify a statistically significant increase in adverse event rates?
Answer: Control charts (SPC) comparing current rates to historical baseline
Statistical Process Control charts allow manufacturers to detect signals that exceed normal variation, objectively flagging when rates have moved beyond expected limits.
Which of the following scenarios represents a 'near miss' that should still be captured in the PMS system even though no injury occurred?
Answer: A device alarmed incorrectly but the clinician caught the error before patient harm
Near-miss events where device performance could have caused harm are valuable PMS data because they signal potential failure modes requiring risk assessment.
Under 21 CFR Part 806, a manufacturer who initiates a recall must submit a written report to FDA within how many days of initiating the removal or correction?
Answer: 10 days
21 CFR Part 806.10 requires manufacturers to submit a written recall report to FDA within 10 working days of initiating a removal or correction.
A manufacturer's EU Authorized Representative receives a serious incident report from a notified body. Under EU MDR Article 87, the manufacturer must report this to which entity?
Answer: The competent authority of the Member State where the incident occurred
Under EU MDR Article 87, serious incidents must be reported to the competent authority of the Member State where the incident took place.