RAC Post-Market Requirements 2

Question 1

Under 21 CFR Part 803, which type of report must a device manufacturer submit to FDA within 30 calendar days of becoming aware of an event?

Accepted Answer

MDR for malfunction that could cause serious injury if it recurs

Answer

21 CFR 803.50 requires manufacturers to submit an MDR within 30 days for malfunctions that, if they were to recur, could cause or contribute to a serious injury.

Question 2

What is the primary purpose of a Post-Market Surveillance (PMS) plan under FDA's Quality System Regulation?

Accepted Answer

To systematically collect and analyze data on device safety and performance after market clearance

Answer

A PMS plan establishes a proactive system to gather and evaluate real-world data on device safety and performance throughout the product lifecycle.

Question 3

Which FDA database is the primary repository for mandatory Medical Device Reports submitted by manufacturers and importers?

Accepted Answer

MAUDE

Answer

The MAUDE (Manufacturer and User Facility Device Experience) database contains MDRs submitted to FDA for adverse events and malfunctions.

Question 4

A device manufacturer receives a complaint that a patient experienced a minor skin irritation from a non-implantable device. Under 21 CFR Part 803, this event is:

Accepted Answer

Not reportable unless the irritation required medical intervention beyond first aid

Answer

MDR reporting is triggered by serious injury (requiring medical or surgical intervention) or death; minor irritation not requiring intervention beyond first aid does not meet the threshold.

Question 5

What distinguishes a 'recall' from a 'market withdrawal' under FDA definitions?

Accepted Answer

Recalls involve products that violate FDA regulations; market withdrawals involve products with minor defects not violating regulations

Answer

A recall involves a product that violates FDA law, while a market withdrawal involves a minor defect or non-violative issue that does not trigger regulatory action.

(RAC) Regulatory Affairs Certification Practice Test

(RAC) Regulatory Affairs Certification Practice Test

RAC Post-Market Requirements 2