RAC Device Exam Simulation | 50-question and Answers
A U.S. manufacturer C
modifies a cleared Class II
diagnostic device by
changing its intended use
from screening to diagnosis of
a condition.
Which FDA submission is most
appropriate?
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. PMA
A U.S. manufacturer becomes B. Submit a 30-day MDR
aware that a Class II device
malfunctioned, and if it
recurred, it could lead to a
serious injury. No injury
occurred this time.
What action must the
manufacturer take?
A. Submit a 5-day MDR
B. Submit a 30-day MDR
C. No MDR is required
D. Report only if a recall is issued
Under EU MDR, what is the C. At least annually
typical frequency of notified
body surveillance audits for
Class IIb devices?
A. Every 2 years
B. Once per product lifecycle
C. At least annually
D. Every 5 years
,A company is developing a C. De Novo
novel Class II wearable
therapeutic device for
insomnia. There is no
predicate device in the U.S.,
and the risk is considered
moderate.
What is the most appropriate
FDA regulatory pathway?
A. PMA
B. Traditional 510(k)
C. De Novo
D. Humanitarian Device
Exemption (HDE)
According to ISO 13485:2016, C. Top Management
who is ultimately responsible
for ensuring the effectiveness
of the QMS?
A. Quality Assurance Manager
B. Regulatory Affairs Lead
C. Top Management
D. Notified Body
A molecular test detects a C. Class C
genetic marker to determine
whether a patient is eligible
for a cancer drug. How is this
test classified under IVDR?
A. Class A
B. Class B
C. Class C
D. Class D
Which of the following is C. Updating IFU to include a new clinical warning
considered a Field Safety
Corrective Action (FSCA)
under EU MDR?
A. Updating marketing materials
B. Correcting a labeling error
unrelated to safety
C. Updating IFU to include a
new clinical warning
D. Internal process revision
with no product changes
, Which of the following C. Drug-eluting coronary stent
devices is most likely to be
classified as Class III in the
U.S.?
A. Digital thermometer
B. Manual toothbrush
C. Drug-eluting coronary stent
D. Surgical mask
Which of the following is the C. To show the device was developed in accordance with design
primary purpose of the Design controls
History File (DHF) under 21
CFR 820.30?
A. To record postmarket
complaints
B. To prove each device
was manufactured correctly
C. To show the device was
developed in accordance
with design controls
D. To describe all labeling
components
A U.S. manufacturer C
modifies a cleared Class II
diagnostic device by
changing its intended use
from screening to diagnosis of
a condition.
Which FDA submission is most
appropriate?
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. PMA
A U.S. manufacturer becomes B. Submit a 30-day MDR
aware that a Class II device
malfunctioned, and if it
recurred, it could lead to a
serious injury. No injury
occurred this time.
What action must the
manufacturer take?
A. Submit a 5-day MDR
B. Submit a 30-day MDR
C. No MDR is required
D. Report only if a recall is issued
Under EU MDR, what is the C. At least annually
typical frequency of notified
body surveillance audits for
Class IIb devices?
A. Every 2 years
B. Once per product lifecycle
C. At least annually
D. Every 5 years
,A company is developing a C. De Novo
novel Class II wearable
therapeutic device for
insomnia. There is no
predicate device in the U.S.,
and the risk is considered
moderate.
What is the most appropriate
FDA regulatory pathway?
A. PMA
B. Traditional 510(k)
C. De Novo
D. Humanitarian Device
Exemption (HDE)
According to ISO 13485:2016, C. Top Management
who is ultimately responsible
for ensuring the effectiveness
of the QMS?
A. Quality Assurance Manager
B. Regulatory Affairs Lead
C. Top Management
D. Notified Body
A molecular test detects a C. Class C
genetic marker to determine
whether a patient is eligible
for a cancer drug. How is this
test classified under IVDR?
A. Class A
B. Class B
C. Class C
D. Class D
Which of the following is C. Updating IFU to include a new clinical warning
considered a Field Safety
Corrective Action (FSCA)
under EU MDR?
A. Updating marketing materials
B. Correcting a labeling error
unrelated to safety
C. Updating IFU to include a
new clinical warning
D. Internal process revision
with no product changes
, Which of the following C. Drug-eluting coronary stent
devices is most likely to be
classified as Class III in the
U.S.?
A. Digital thermometer
B. Manual toothbrush
C. Drug-eluting coronary stent
D. Surgical mask
Which of the following is the C. To show the device was developed in accordance with design
primary purpose of the Design controls
History File (DHF) under 21
CFR 820.30?
A. To record postmarket
complaints
B. To prove each device
was manufactured correctly
C. To show the device was
developed in accordance
with design controls
D. To describe all labeling
components
