RAC Postmarket Surveillance and Compliance 2 — Questions and Answers
Question 1: Under 21 CFR Part 803, what is the timeframe for submitting a Medical Device Report (MDR) for a death or serious injury caused by a device?
- 5 calendar days
- 10 calendar days (Correct answer)
- 30 calendar days
- 45 calendar days
Correct answer: 10 calendar days
Manufacturers must submit MDRs for deaths or serious injuries within 30 calendar days of becoming aware of the event.
Question 2: A manufacturer receives a complaint that a device malfunctioned but caused no injury. Under MDR regulations, when must this be reported to FDA?
- 5 calendar days
- 10 calendar days
- 30 calendar days (Correct answer)
- Only if it happens again
Correct answer: 30 calendar days
Malfunctions that could cause or contribute to a serious injury if they were to recur must be reported within 30 calendar days.
Question 3: Which of the following is the primary EU regulation governing postmarket surveillance for medical devices?
- Directive 93/42/EEC (MDD)
- Regulation (EU) 2017/745 (MDR) (Correct answer)
- Directive 90/385/EEC (AIMDD)
- Regulation (EU) 2017/746 (IVDR)
Correct answer: Regulation (EU) 2017/745 (MDR)
EU Regulation 2017/745 (MDR) is the primary regulation governing medical device postmarket surveillance in the EU, replacing MDD.
Question 4: What does a Periodic Safety Update Report (PSUR) under EU MDR require for Class IIb devices?
- Submission every 5 years
- Submission every 3 years
- Submission every 2 years (Correct answer)
- Annual submission
Correct answer: Submission every 2 years
Under EU MDR, PSURs for Class IIb devices must be submitted to the Notified Body every 2 years.
Question 5: In the context of postmarket surveillance, what is a 'Field Safety Corrective Action' (FSCA)?
- An internal recall confined to warehouse inventory
- An action taken to reduce risk of death or serious injury from a device already on the market (Correct answer)
- A regulatory fine imposed by a competent authority
- A voluntary withdrawal of a product before market approval
Correct answer: An action taken to reduce risk of death or serious injury from a device already on the market
An FSCA is any action taken by a manufacturer to reduce risk of death or serious injury associated with a device already in distribution or use.
Question 6: Under FDA's postmarket surveillance authority (21 CFR Part 822), which device classification typically triggers a mandatory postmarket surveillance study order?
- Class I exempt devices only
- Class II devices with special controls
- Class III devices or Class II devices presenting serious adverse health consequences (Correct answer)
- Any device that has received at least one MDR
Correct answer: Class III devices or Class II devices presenting serious adverse health consequences
FDA can order postmarket surveillance studies for Class III or Class II devices that could cause serious adverse health consequences.
Question 7: What is the purpose of a 'Trend Report' under 21 CFR Part 803?
- To report annual sales volumes to FDA
- To notify FDA of increased rates of device-related events that exceed baseline thresholds (Correct answer)
- To summarize competitor device recalls
- To document changes in manufacturing processes
Correct answer: To notify FDA of increased rates of device-related events that exceed baseline thresholds
Trend reports notify FDA when MDR event rates exceed established baseline thresholds, signaling a potential safety signal.
RAC Postmarket Surveillance and Compliance 2
Under 21 CFR Part 803, what is the timeframe for submitting a Medical Device Report (MDR) for a death or serious injury caused by a device?