RAC DEVICES ACTUAL EXAM #3 QUESTIONS
WITH VERIFIED ANSWERS
(True/False): In the US, clinical study files need to be maintained for a minimum of 2 years
after the study ends.
True
Explanation: In the US, clinical study files must be retained for at least 2 years after the study
has ended. In the EU, this period can be much longer, depending on the study and specific
regulatory requirements.
What is the standard review time for a traditional 510(k)?
A) 30 days
B) 90 days
C) 120 days
D) 180 days
B) 90 days
Explanation: The FDA's goal for a traditional 510(k) submission is to provide a decision within
90 calendar days, although this time frame can vary depending on the complexity of the device
and completeness of the submission
Which of the following countries are members of the International Medical Device
Regulators Forum (IMDRF)?
A) United States, China, Brazil, European Union
B) United States, India, Japan, Mexico
C) United States, Canada, Australia, European Union, Japan
D) United States, Canada, Russia, Japan
C) United States, Canada, Australia, European Union, Japan
Explanation: IMDRF members include the US, Canada, Australia, Japan, the European Union,
Brazil, and China. These countries collaborate to harmonize regulatory approaches for medical
devices.
How many days after Investigational Device Exemption (IDE) approval can a clinical study
begin?
A) 10 days
B) 30 days
C) 45 days
D) Immediately after approval
B) 30 days
,Explanation: After IDE approval, a clinical study can begin 30 days post-approval, provided all
other regulatory conditions have been satisfied.
A medical device is recalled because it may cause temporary and reversible health effects
that could lead to hospitalization. What class of recall does this represent?
A) Class I
B) Class II
C) Class III
B) Class II
Explanation: A Class II recall typically involves devices that could cause temporary or
medically reversible adverse health consequences. Class I involves a higher risk of serious harm,
and Class III involves minimal risk.
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.
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.
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
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
Explanation: Class II recalls involve devices that may cause temporary or medically reversible
health consequences. Class I involves a serious risk, while Class III involves minimal risk.
Your quality team is reviewing standards to ensure compliance with international Good
Manufacturing Practices (GMP). Which ISO standard covers GMP for medical devices?
A) ISO 13485
B) ISO 9001
C) ISO 14155
D) ISO 14971
A) ISO 13485
Explanation: ISO 13485 is the standard for medical devices' quality management systems and
covers the GMP requirements for the industry.
(True/False): Your EU-based company is appointing a Person Responsible for Regulatory
Compliance (PRRC). Can this role be fulfilled by a third-party contractor with relevant
expertise?
True
Explanation: The PRRC can be an external contractor as long as they have the appropriate
qualifications, experience, and responsibilities to ensure regulatory compliance for the
organization.
Your company plans to export a Class III medical device from the US to a non-EU country.
What documentation would most likely be required?
A) Certificate of Free Sale
B) Certificate of Conformity
C) Certificate of Exportability
D) Certificate of Foreign Government
D) Certificate of Foreign Government
Explanation: The Certificate of Foreign Government is typically required when exporting a
medical device to a non-EU country and ensures that the device complies with the foreign
country’s regulations.
WITH VERIFIED ANSWERS
(True/False): In the US, clinical study files need to be maintained for a minimum of 2 years
after the study ends.
True
Explanation: In the US, clinical study files must be retained for at least 2 years after the study
has ended. In the EU, this period can be much longer, depending on the study and specific
regulatory requirements.
What is the standard review time for a traditional 510(k)?
A) 30 days
B) 90 days
C) 120 days
D) 180 days
B) 90 days
Explanation: The FDA's goal for a traditional 510(k) submission is to provide a decision within
90 calendar days, although this time frame can vary depending on the complexity of the device
and completeness of the submission
Which of the following countries are members of the International Medical Device
Regulators Forum (IMDRF)?
A) United States, China, Brazil, European Union
B) United States, India, Japan, Mexico
C) United States, Canada, Australia, European Union, Japan
D) United States, Canada, Russia, Japan
C) United States, Canada, Australia, European Union, Japan
Explanation: IMDRF members include the US, Canada, Australia, Japan, the European Union,
Brazil, and China. These countries collaborate to harmonize regulatory approaches for medical
devices.
How many days after Investigational Device Exemption (IDE) approval can a clinical study
begin?
A) 10 days
B) 30 days
C) 45 days
D) Immediately after approval
B) 30 days
,Explanation: After IDE approval, a clinical study can begin 30 days post-approval, provided all
other regulatory conditions have been satisfied.
A medical device is recalled because it may cause temporary and reversible health effects
that could lead to hospitalization. What class of recall does this represent?
A) Class I
B) Class II
C) Class III
B) Class II
Explanation: A Class II recall typically involves devices that could cause temporary or
medically reversible adverse health consequences. Class I involves a higher risk of serious harm,
and Class III involves minimal risk.
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.
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.
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
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
Explanation: Class II recalls involve devices that may cause temporary or medically reversible
health consequences. Class I involves a serious risk, while Class III involves minimal risk.
Your quality team is reviewing standards to ensure compliance with international Good
Manufacturing Practices (GMP). Which ISO standard covers GMP for medical devices?
A) ISO 13485
B) ISO 9001
C) ISO 14155
D) ISO 14971
A) ISO 13485
Explanation: ISO 13485 is the standard for medical devices' quality management systems and
covers the GMP requirements for the industry.
(True/False): Your EU-based company is appointing a Person Responsible for Regulatory
Compliance (PRRC). Can this role be fulfilled by a third-party contractor with relevant
expertise?
True
Explanation: The PRRC can be an external contractor as long as they have the appropriate
qualifications, experience, and responsibilities to ensure regulatory compliance for the
organization.
Your company plans to export a Class III medical device from the US to a non-EU country.
What documentation would most likely be required?
A) Certificate of Free Sale
B) Certificate of Conformity
C) Certificate of Exportability
D) Certificate of Foreign Government
D) Certificate of Foreign Government
Explanation: The Certificate of Foreign Government is typically required when exporting a
medical device to a non-EU country and ensures that the device complies with the foreign
country’s regulations.
