RAC PREP MEDICAL DEVICES 2025) COMPREHENSIVE
QUESTIONS AND VERIFIED ANSWERS (DETAILED &
ELABORATED) ACTUAL EXAM 2025 TEST 100% SOLVED 2025!!
Question 1
Which of the following is a characteristic of a "device" as defined in the provided text?
A) Its primary purpose is achieved through chemical action.
B) It is dependent on metabolism for its primary purpose.
C) It is exclusively an in vitro reagent.
D) It is intended to affect the structure or function of the body.
E) It is primarily recognized by a non-governmental organization.
Correct Answer: D) intended to affect the structure or function of the body
Rationale: The provided text lists "intended to affect the structure or function of the
body" as a characteristic of a device.
Question 2
An exempt device is not subject to 510(k) if:
A) It is invasive.
B) It introduces energy into the subject.
C) It is a diagnostic device in distribution before May 28, 1976, and not a
transitional device.
D) It requires clinical trials.
E) It is used for diagnosis without any confirmation.
Correct Answer: C) Diagnostic device that was in distribution before 28MAY76, not a
transitional device
Rationale: The provided text states, "Exempt device Exempt from 510(k) if: -
, Diagnostic device that was in distribution before 28MAY76, not a transitional
device".
Question 3
Which agency approves devices used for collecting, processing, storing, and administering blood
products?
A) CDRH
B) CVM
C) CDER
D) ORA
E) CBER
Correct Answer: E) CBER
Rationale: The provided text states, "Devices used for collecting, processing, storing
and administering blood products Approved by CBER as devices (510(k) or PMA)".
Question 4
Any device or accessory to any device that is suitable for use or capable of functioning, whether
or not it is packaged, labeled, or sterilized, is a:
A) Component
B) Accessory
C) Subassembly
D) Finished device
E) Raw material
Correct Answer: D) finished device
Rationale: The provided text defines "finished device" as "any device or accessory to
QUESTIONS AND VERIFIED ANSWERS (DETAILED &
ELABORATED) ACTUAL EXAM 2025 TEST 100% SOLVED 2025!!
Question 1
Which of the following is a characteristic of a "device" as defined in the provided text?
A) Its primary purpose is achieved through chemical action.
B) It is dependent on metabolism for its primary purpose.
C) It is exclusively an in vitro reagent.
D) It is intended to affect the structure or function of the body.
E) It is primarily recognized by a non-governmental organization.
Correct Answer: D) intended to affect the structure or function of the body
Rationale: The provided text lists "intended to affect the structure or function of the
body" as a characteristic of a device.
Question 2
An exempt device is not subject to 510(k) if:
A) It is invasive.
B) It introduces energy into the subject.
C) It is a diagnostic device in distribution before May 28, 1976, and not a
transitional device.
D) It requires clinical trials.
E) It is used for diagnosis without any confirmation.
Correct Answer: C) Diagnostic device that was in distribution before 28MAY76, not a
transitional device
Rationale: The provided text states, "Exempt device Exempt from 510(k) if: -
, Diagnostic device that was in distribution before 28MAY76, not a transitional
device".
Question 3
Which agency approves devices used for collecting, processing, storing, and administering blood
products?
A) CDRH
B) CVM
C) CDER
D) ORA
E) CBER
Correct Answer: E) CBER
Rationale: The provided text states, "Devices used for collecting, processing, storing
and administering blood products Approved by CBER as devices (510(k) or PMA)".
Question 4
Any device or accessory to any device that is suitable for use or capable of functioning, whether
or not it is packaged, labeled, or sterilized, is a:
A) Component
B) Accessory
C) Subassembly
D) Finished device
E) Raw material
Correct Answer: D) finished device
Rationale: The provided text defines "finished device" as "any device or accessory to
