RAC Post-Market Requirements 3 — Questions and Answers
Question 1: In the EU MDR (Regulation 2017/745), what is the minimum frequency for periodic safety update reports (PSURs) for Class IIb implantable devices?
- Every five years
- Every three years
- Annually (Correct answer)
- Only when a serious incident occurs
Correct answer: Annually
Under EU MDR Article 86, PSURs for Class IIb implantable devices must be updated at least annually.
Question 2: A 'Field Safety Corrective Action' (FSCA) under EU MDR is best described as:
- An action taken by FDA to mandate a recall
- A manufacturer-initiated action to reduce risk of death or serious injury associated with a device already on the market (Correct answer)
- A notified body audit finding requiring corrective action
- A competent authority inspection outcome
Correct answer: A manufacturer-initiated action to reduce risk of death or serious injury associated with a device already on the market
An FSCA is a voluntary or mandated manufacturer action taken in the field to reduce risk associated with a device already in use or distributed.
Question 3: Under 21 CFR Part 820 (QSR), what is the required timeframe for completing an investigation of a complaint involving a device that could have caused or contributed to serious injury?
- Within 5 business days
- As soon as practicable (Correct answer)
- Within 30 calendar days
- Within 60 calendar days
Correct answer: As soon as practicable
21 CFR 820.198 requires that complaint investigations be completed as soon as practicable, with no fixed deadline, but in a timeframe appropriate to the severity.
Question 4: What is a 'Summary Safety and Effectiveness Data' (SSED) document in the context of FDA post-market activities?
- A document submitted with every MDR
- A publicly available document FDA prepares for PMA-approved devices summarizing safety and effectiveness (Correct answer)
- An internal manufacturer document required under QSR
- A recall notification letter sent to device users
Correct answer: A publicly available document FDA prepares for PMA-approved devices summarizing safety and effectiveness
SSEDs are publicly posted by FDA summarizing the safety and effectiveness data supporting PMA approval decisions.
Question 5: Post-Approval Studies (PAS) required as a condition of PMA approval are governed by which FDA regulation?
- 21 CFR Part 803
- 21 CFR Part 822 (Correct answer)
- 21 CFR Part 806
- 21 CFR Part 812
Correct answer: 21 CFR Part 822
21 CFR Part 822 establishes FDA's authority to require post-market surveillance studies as a condition of PMA approval.
Question 6: Which signal detection method involves reviewing spontaneous adverse event reports to identify unexpected patterns of device-related harm?
- Randomized controlled trial
- Disproportionality analysis (Correct answer)
- Design FMEA
- Process validation study
Correct answer: Disproportionality analysis
Disproportionality analysis is a statistical method used in pharmacovigilance and device surveillance to detect unexpected signals in spontaneous report databases.
Question 7: Under EU MDR, Serious Incidents must be reported to the relevant competent authority within what timeframe when the incident has caused or might have caused a serious public health threat?
- Immediately, without undue delay and no later than 2 days after the manufacturer becomes aware (Correct answer)
- Within 7 calendar days
- Within 15 calendar days
- Within 30 calendar days
Correct answer: Immediately, without undue delay and no later than 2 days after the manufacturer becomes aware
EU MDR Article 87 requires that serious public health threats be reported immediately and no later than 2 days after the manufacturer becomes aware.
RAC Post-Market Requirements 3
In the EU MDR (Regulation 2017/745), what is the minimum frequency for periodic safety update reports (PSURs) for Class IIb implantable devices?