RAC Post-Market Surveillance 2

Question 1

Under FDA regulations, which event involving a marketed device MUST be reported on a MedWatch 3500A form within 30 days?

Accepted Answer

A device malfunction that could cause serious injury if it recurs

Answer

MDR regulations require a 30-day report for malfunctions that could cause or contribute to serious injury or death if they were to recur.

Question 2

What is the primary purpose of a Post-Market Clinical Follow-Up (PMCF) study for a medical device?

Accepted Answer

To collect additional clinical data confirming safety and performance in real-world use

Answer

PMCF proactively gathers clinical evidence from post-market use to confirm ongoing safety and performance and address residual uncertainties.

Question 3

Which FDA database is the PRIMARY source manufacturers must search when evaluating complaints for potential MDR reportability?

Accepted Answer

MAUDE (Manufacturer and User Facility Device Experience)

Answer

MAUDE contains MDRs submitted by manufacturers, importers, and device facilities, making it the primary reference for evaluating complaint trends and MDR precedents.

Question 4

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?

Accepted Answer

The device manufacturer

Answer

Under 21 CFR Part 803, manufacturers hold primary MDR reporting responsibility; distributors are required reporters only in specific circumstances defined in the regulation.

Question 5

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?

Accepted Answer

Periodic Safety Update Report (PSUR)

Answer

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.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Post-Market Surveillance 2