RAC Post-Market Requirements 3

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?

Accepted Answer

Annually

Answer

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:

Accepted Answer

A manufacturer-initiated action to reduce risk of death or serious injury associated with a device already on the market

Answer

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?

Accepted Answer

As soon as practicable

Answer

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?

Accepted Answer

A publicly available document FDA prepares for PMA-approved devices summarizing safety and effectiveness

Answer

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?

Accepted Answer

21 CFR Part 822

Answer

21 CFR Part 822 establishes FDA's authority to require post-market surveillance studies as a condition of PMA approval.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Post-Market Requirements 3