Page 1 of 75
Device RAC Medical PRACTICE EXAM QUESTIONS
AND CORRECT DETAILED RATIONALISED
SOLUTIONS LATEST UPDATED VERSION JUST
RELEASED NEWEST!!
Which ISO standard covers Good Manufacturing Practices (GMP) for medical devices?
A) ISO 9001
B) ISO 13485
C) ISO 14971
D) ISO 14155
B) ISO 13485
Explanation: ISO 13485 specifies requirements for a quality management system where an
organization needs to demonstrate its ability to provide medical devices that consistently meet
customer and regulatory requirements.
(True/False): The PRRC must be a full-time employee of the company based in the EU.
False
Explanation: The PRRC does not need to be a full-time employee but must have a sufficient
level of responsibility and competence to ensure regulatory compliance. They can also be
contracted, as long as the individual fulfills the requirements of the role.
, Page 2 of 75
Your company is making minor changes to the labeling of a device. What type of 510(k)
submission is most appropriate?
A) Traditional 510(k)
B) Abbreviated 510(k)
C) Special 510(k)
C) Special 510(k)
Explanation: Minor changes, such as to labeling, may be submitted under a Special 510(k) as
long as the changes do not affect the device's intended use or alter the fundamental scientific
technology.
Your company has just completed a clinical study on a medical device in both the US and EU.
You are responsible for maintaining study files. For how long must you retain these files to
comply with US and EU regulations?
A) 2 years in the US and 5 years in the EU
B) 2 years in the US and 10 years in the EU
C) 5 years in the US and 5 years in the EU
D) 10 years in the US and 10 years in the EU
B) 2 years in the US and 10 years in the EU
Explanation: In the US, clinical study files must be maintained for at least 2 years after the study
ends. In the EU, retention periods are typically longer, with a standard requirement of 10 years
or more, depending on the device and national regulations.
, Page 3 of 75
Your company is planning to launch a new medical device globally. You want to ensure
compliance with IMDRF member countries' regulations. Which of the following groups
represents the correct member countries of the IMDRF?
A) US, Canada, Australia, EU, Japan, China, Brazil
B) US, India, Japan, Mexico, South Africa
C) US, UK, Brazil, Russia, China
D) US, Japan, India, South Africa, Brazil
A) US, Canada, Australia, EU, Japan, China, Brazil
Explanation: The IMDRF includes the US, Canada, Australia, Japan, the European Union, Brazil,
and China. These countries collaborate on harmonizing medical device regulations.
Your company submitted a traditional 510(k) application for a new Class II medical device. The
team is eager to get the device to market as soon as possible. What is the typical review
timeline that the FDA aims to meet for a traditional 510(k)?
A) 60 days
B) 90 days
C) 120 days
D) 180 days
B) 90 days
, Page 4 of 75
Explanation: The FDA’s goal is to review and provide a decision on traditional 510(k)
applications within 90 calendar days, although the actual time may vary depending on the
specifics of the submission.
Your company has received IDE approval from the FDA for a new clinical study. How long after
approval must you wait before beginning the study?
A) 10 days
B) 30 days
C) 45 days
D) No waiting period, you can begin immediately
B) 30 days
Explanation: After obtaining IDE approval, the study can commence 30 days later, allowing time
for all necessary preparations and adherence to regulatory requirements.
A medical device has been recalled due to a defect that could result in temporary, reversible
adverse health consequences that might require hospitalization. What class of recall does this
situation fall under?
A) Class I
B) Class II
C) Class III
B) Class II
Device RAC Medical PRACTICE EXAM QUESTIONS
AND CORRECT DETAILED RATIONALISED
SOLUTIONS LATEST UPDATED VERSION JUST
RELEASED NEWEST!!
Which ISO standard covers Good Manufacturing Practices (GMP) for medical devices?
A) ISO 9001
B) ISO 13485
C) ISO 14971
D) ISO 14155
B) ISO 13485
Explanation: ISO 13485 specifies requirements for a quality management system where an
organization needs to demonstrate its ability to provide medical devices that consistently meet
customer and regulatory requirements.
(True/False): The PRRC must be a full-time employee of the company based in the EU.
False
Explanation: The PRRC does not need to be a full-time employee but must have a sufficient
level of responsibility and competence to ensure regulatory compliance. They can also be
contracted, as long as the individual fulfills the requirements of the role.
, Page 2 of 75
Your company is making minor changes to the labeling of a device. What type of 510(k)
submission is most appropriate?
A) Traditional 510(k)
B) Abbreviated 510(k)
C) Special 510(k)
C) Special 510(k)
Explanation: Minor changes, such as to labeling, may be submitted under a Special 510(k) as
long as the changes do not affect the device's intended use or alter the fundamental scientific
technology.
Your company has just completed a clinical study on a medical device in both the US and EU.
You are responsible for maintaining study files. For how long must you retain these files to
comply with US and EU regulations?
A) 2 years in the US and 5 years in the EU
B) 2 years in the US and 10 years in the EU
C) 5 years in the US and 5 years in the EU
D) 10 years in the US and 10 years in the EU
B) 2 years in the US and 10 years in the EU
Explanation: In the US, clinical study files must be maintained for at least 2 years after the study
ends. In the EU, retention periods are typically longer, with a standard requirement of 10 years
or more, depending on the device and national regulations.
, Page 3 of 75
Your company is planning to launch a new medical device globally. You want to ensure
compliance with IMDRF member countries' regulations. Which of the following groups
represents the correct member countries of the IMDRF?
A) US, Canada, Australia, EU, Japan, China, Brazil
B) US, India, Japan, Mexico, South Africa
C) US, UK, Brazil, Russia, China
D) US, Japan, India, South Africa, Brazil
A) US, Canada, Australia, EU, Japan, China, Brazil
Explanation: The IMDRF includes the US, Canada, Australia, Japan, the European Union, Brazil,
and China. These countries collaborate on harmonizing medical device regulations.
Your company submitted a traditional 510(k) application for a new Class II medical device. The
team is eager to get the device to market as soon as possible. What is the typical review
timeline that the FDA aims to meet for a traditional 510(k)?
A) 60 days
B) 90 days
C) 120 days
D) 180 days
B) 90 days
, Page 4 of 75
Explanation: The FDA’s goal is to review and provide a decision on traditional 510(k)
applications within 90 calendar days, although the actual time may vary depending on the
specifics of the submission.
Your company has received IDE approval from the FDA for a new clinical study. How long after
approval must you wait before beginning the study?
A) 10 days
B) 30 days
C) 45 days
D) No waiting period, you can begin immediately
B) 30 days
Explanation: After obtaining IDE approval, the study can commence 30 days later, allowing time
for all necessary preparations and adherence to regulatory requirements.
A medical device has been recalled due to a defect that could result in temporary, reversible
adverse health consequences that might require hospitalization. What class of recall does this
situation fall under?
A) Class I
B) Class II
C) Class III
B) Class II
