RAC DEVICES ACTUAL EXAM #2 QUESTIONS
WITH VERIFIED ANSWERS
A U.S. manufacturer 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
C
A U.S. manufacturer becomes 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
B. Submit a 30-day MDR
Under EU MDR, what is the 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
C. At least annually
A company is developing a 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)
C. De Novo
According to ISO 13485:2016, 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
C. Top Management
A molecular test detects a 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
C. Class C
Which of the following is 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
C. Updating IFU to include a new clinical warning
Which of the following 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
C. Drug-eluting coronary stent
Which of the following is the primary purpose of the Design 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
C. To show the device was developed in accordance with design controls
A manufacturer of a Class IIb electrically powered, sterile infusion pump wishes to CE
mark the device under EU MDR. The manufacturer has an ISO 13485-certified QMS.
Which conformity assessment route(s) are most appropriate?
A. Annex VII - Self-certification
B. Annex XI - Part A (Type Exam only)
C. Annex IX (Full QMS audit with product assessment) or Annex X + XI
D. Annex VIII - Classification rules only
WITH VERIFIED ANSWERS
A U.S. manufacturer 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
C
A U.S. manufacturer becomes 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
B. Submit a 30-day MDR
Under EU MDR, what is the 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
C. At least annually
A company is developing a 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)
C. De Novo
According to ISO 13485:2016, 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
C. Top Management
A molecular test detects a 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
C. Class C
Which of the following is 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
C. Updating IFU to include a new clinical warning
Which of the following 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
C. Drug-eluting coronary stent
Which of the following is the primary purpose of the Design 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
C. To show the device was developed in accordance with design controls
A manufacturer of a Class IIb electrically powered, sterile infusion pump wishes to CE
mark the device under EU MDR. The manufacturer has an ISO 13485-certified QMS.
Which conformity assessment route(s) are most appropriate?
A. Annex VII - Self-certification
B. Annex XI - Part A (Type Exam only)
C. Annex IX (Full QMS audit with product assessment) or Annex X + XI
D. Annex VIII - Classification rules only
