CCRP SOCRA Exam 21 CFR Part 812 Practice Test 2026 |
Verified Answers | Exam Prep
1. What is the definition of 'noninvasive' in the context of diagnostic devices?
A procedure that does not require entering the body or breaking the
skin.
A procedure that involves surgical intervention.
A procedure that requires anesthesia.
A procedure that uses radiation.
2. A diagnostic device is exempt from IDE requirements if:
It is noninvasive
It does not require an invasive sampling procedure
It does not introduce energy into the subject
It is not used as a diagnostic procedure without confirmation by an
established procedure
All of the above
3. A sponsor shall submit an application to the FDA if the sponsor intends to use
a(n) _________ in an investigation, intends to conduct an investigation that
involves an exception from informed consent under 21 CFR 812 part 50.24, or
if FDA notifies the sponsor than an application is required for an investigation.
implant
investigational device
significant risk device
non-invasive device
,4. According to 21 CFR Part 812, what is the minimum number of subjects
required for an investigation involving a medical device?
5-25
one or more
hundreds to thousands
25-100
5. If a new investigational device is being labeled and the manufacturer fails to
include the required information about hazards and precautions, what
potential consequences could arise?
The device will automatically be approved for market use.
The device will be exempt from all regulations.
There will be no consequences as long as the device is effective.
The manufacturer could face regulatory penalties and the device
may be deemed non-compliant with FDA regulations.
The manufacturer will receive a warning but can continue to market
the device.
6. Describe the criteria that classify a device as a significant risk device under
Title 21 CFR Part 812.
A significant risk device is one that is non-invasive and poses minimal
risk.
A significant risk device is a device that does not require FDA
approval.
A significant risk device is any device that is used in a clinical trial.
A significant risk device is one that poses a potential for serious risk
to the health, safety, or welfare of a subject.
, 7. In 21 CFR Part 812, to what does "Implant" refer?
Device, including a transitional device, that is the object of an
investigation
Device that is placed into a surgically or naturally formed cavity of
the human body if it is intended to remain there for a period of 30
days or more
8. What does Title 21 CFR Part 812 define as an 'unanticipated adverse device
effect'?
An effect that is not expected based on the information available
about the device.
An effect that is related to the device's design and intended use.
An effect that occurs during the manufacturing process of the device.
An effect that is expected and documented in the device's labeling.
9. If a new medical device is being tested in a clinical trial, which regulation
must the sponsors comply with, as indicated by the term 'Act' in 21 CFR Part
812?
Medical Device Safety Act
Federal Food, Drug, and Cosmetic Act
Health Insurance Portability and Accountability Act
Clinical Trial Registration Act
10. In a clinical trial, if a new device is classified as a significant risk device, what
steps must the sponsor take to comply with FDA regulations?
The sponsor must submit an Investigational Device Exemption (IDE)
application to the FDA.
Verified Answers | Exam Prep
1. What is the definition of 'noninvasive' in the context of diagnostic devices?
A procedure that does not require entering the body or breaking the
skin.
A procedure that involves surgical intervention.
A procedure that requires anesthesia.
A procedure that uses radiation.
2. A diagnostic device is exempt from IDE requirements if:
It is noninvasive
It does not require an invasive sampling procedure
It does not introduce energy into the subject
It is not used as a diagnostic procedure without confirmation by an
established procedure
All of the above
3. A sponsor shall submit an application to the FDA if the sponsor intends to use
a(n) _________ in an investigation, intends to conduct an investigation that
involves an exception from informed consent under 21 CFR 812 part 50.24, or
if FDA notifies the sponsor than an application is required for an investigation.
implant
investigational device
significant risk device
non-invasive device
,4. According to 21 CFR Part 812, what is the minimum number of subjects
required for an investigation involving a medical device?
5-25
one or more
hundreds to thousands
25-100
5. If a new investigational device is being labeled and the manufacturer fails to
include the required information about hazards and precautions, what
potential consequences could arise?
The device will automatically be approved for market use.
The device will be exempt from all regulations.
There will be no consequences as long as the device is effective.
The manufacturer could face regulatory penalties and the device
may be deemed non-compliant with FDA regulations.
The manufacturer will receive a warning but can continue to market
the device.
6. Describe the criteria that classify a device as a significant risk device under
Title 21 CFR Part 812.
A significant risk device is one that is non-invasive and poses minimal
risk.
A significant risk device is a device that does not require FDA
approval.
A significant risk device is any device that is used in a clinical trial.
A significant risk device is one that poses a potential for serious risk
to the health, safety, or welfare of a subject.
, 7. In 21 CFR Part 812, to what does "Implant" refer?
Device, including a transitional device, that is the object of an
investigation
Device that is placed into a surgically or naturally formed cavity of
the human body if it is intended to remain there for a period of 30
days or more
8. What does Title 21 CFR Part 812 define as an 'unanticipated adverse device
effect'?
An effect that is not expected based on the information available
about the device.
An effect that is related to the device's design and intended use.
An effect that occurs during the manufacturing process of the device.
An effect that is expected and documented in the device's labeling.
9. If a new medical device is being tested in a clinical trial, which regulation
must the sponsors comply with, as indicated by the term 'Act' in 21 CFR Part
812?
Medical Device Safety Act
Federal Food, Drug, and Cosmetic Act
Health Insurance Portability and Accountability Act
Clinical Trial Registration Act
10. In a clinical trial, if a new device is classified as a significant risk device, what
steps must the sponsor take to comply with FDA regulations?
The sponsor must submit an Investigational Device Exemption (IDE)
application to the FDA.
