RAC Post-Market Requirements 2 — Questions and Answers
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?
- Annual product report
- MDR for malfunction that could cause serious injury if it recurs (Correct answer)
- Periodic safety update report
- Field safety corrective action report
Correct answer: MDR for malfunction that could cause serious injury if it recurs
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?
- To satisfy annual inspection requirements
- To systematically collect and analyze data on device safety and performance after market clearance (Correct answer)
- To replace pre-market clinical data submissions
- To document manufacturing process changes
Correct answer: To systematically collect and analyze data on device safety and performance after market clearance
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?
- FAERS
- MAUDE (Correct answer)
- GUDID
- eCTD
Correct answer: MAUDE
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:
- Reportable as a 30-day MDR
- Reportable as a 5-day MDR
- Not reportable unless the irritation required medical intervention beyond first aid (Correct answer)
- Automatically subject to a field correction
Correct answer: Not reportable unless the irritation required medical intervention beyond first aid
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?
- Recalls involve products that violate FDA regulations; market withdrawals involve products with minor defects not violating regulations (Correct answer)
- Recalls are voluntary; market withdrawals are FDA-mandated
- Recalls apply only to drugs; market withdrawals apply only to devices
- Recalls require court orders; market withdrawals do not
Correct answer: Recalls involve products that violate FDA regulations; market withdrawals involve products with minor defects not violating regulations
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.
Question 6: Under 21 CFR Part 806, manufacturers are required to report to FDA device corrections and removals that are initiated to:
- Reduce a risk to health posed by the device or to remedy a violation of the FD&C Act (Correct answer)
- Improve aesthetic characteristics of the device
- Update device labeling for marketing purposes only
- Replace obsolete components with no safety impact
Correct answer: Reduce a risk to health posed by the device or to remedy a violation of the FD&C Act
21 CFR 806.10 requires reporting of corrections or removals undertaken to reduce a risk to health or to remedy a regulatory violation.
Question 7: Which of the following is NOT a recognized class of recall under FDA's classification system?
- Class I — reasonable probability of serious adverse health consequences or death
- Class II — may cause temporary or medically reversible adverse health consequences
- Class III — unlikely to cause adverse health consequences
- Class IV — defects with no health risk that do not require notification (Correct answer)
Correct answer: Class IV — defects with no health risk that do not require notification
FDA uses only Class I, II, and III recall classifications; there is no Class IV recall designation.
RAC Post-Market Requirements 2
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?