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 FDA regulations, which event involving a marketed device MUST be reported on a MedWatch 3500A form within 30 days?
Answer: A device malfunction that could cause serious injury if it recurs
MDR regulations require a 30-day report for malfunctions that could cause or contribute to serious injury or death if they were to recur.
What is the primary purpose of a Post-Market Clinical Follow-Up (PMCF) study for a medical device?
Answer: To collect additional clinical data confirming safety and performance in real-world use
PMCF proactively gathers clinical evidence from post-market use to confirm ongoing safety and performance and address residual uncertainties.
Which FDA database is the PRIMARY source manufacturers must search when evaluating complaints for potential MDR reportability?
Answer: MAUDE (Manufacturer and User Facility Device Experience)
MAUDE contains MDRs submitted by manufacturers, importers, and device facilities, making it the primary reference for evaluating complaint trends and MDR precedents.
A distributor receives a serious injury complaint for a device manufactured by a third party. Under 21 CFR Part 803, who bears the primary MDR reporting obligation?
Answer: The device manufacturer
Under 21 CFR Part 803, manufacturers hold primary MDR reporting responsibility; distributors are required reporters only in specific circumstances defined in the regulation.
Which EU MDR 2017/745 document must be updated at least every 5 years (for Class III devices, more frequently) and summarize the PMS conclusions?
Answer: Periodic Safety Update Report (PSUR)
The PSUR, required under EU MDR Article 86, synthesizes post-market surveillance data and must be updated at defined intervals based on device risk class.
In a risk management context, how should new post-market safety information that reveals an unacceptable risk-benefit ratio be handled?
Answer: Feed it back into the risk management file and reassess risk controls
ISO 14971 requires that post-production information be evaluated and, if it indicates an unacceptable risk, fed back into the risk management process to update controls.
A manufacturer identifies through PMS that a device component is failing at a rate higher than predicted in the design phase. What is the MOST appropriate immediate next step?
Answer: Conduct a root cause analysis and assess whether a CAPA or field action is needed
Discovering an unexpected failure rate requires root cause analysis and a CAPA assessment to determine if a field safety corrective action is necessary.