Device RAC Exam (New 2026/ 2027
Update) Questions & Answers 100%
Correct (Verified Solutions) - {Grade A}
A legally marketed device to which equivalence is drawn in a premarketing submission
is known as the:
A. Comparator device
B. Predecessor device
C. Predicate device
D. Substantially equivalent device - Correct answer C. Predicate device
An identification of the legally marketed device to which the submitter claims
equivalence. A legally marketed device to which a new device may be compared for a
determination regarding substantial equivalence is a device that was legally marketed
prior to May 28, 1976, or a device which has been reclassified from class III to class II
or I (the predicate), or a device which has been found to be substantially equivalent
through the 510(k) premarket notification process; 21 CFR 807.100(b). The data
submitted establishes that the device is substantially equivalent to the predicate
,device and contains information, including clinical data if deemed necessary by the
Commissioner, that demonstrates that the device is as safe and as effective as a
legally marketed device.
The QSR includes requirements for Design Controls. All of the following statements
about Design Reviews are true EXCEPT:
A. Mfgers required to maintain procedures to ensure formal reviews occur at
appropriate stages of design and dev
B. Participation at design reviews must include reps of all fxns concerned with the
stage being reviewed.
C. Participation shall include at least one individual who does not have direct
responsibility for stage being reviewed.
D. Results of design review shall be documented in the device history record. - Correct
answer D. Results of design review shall be documented in the device history record.
The results of the design review shall be documented in the device history file (DHF);
see 21 CFR 820.30(e).
,A humanitarian device exemption (HDE) differs from a traditional PMA in that:
A. It does not require compliance with QSR.
B. Non-clinical data are not required.
C. Effectiveness data are not required.
D. Device characteristics are not required. - Correct answer C. Effectiveness data are
not required.
A company wants to modify its device such that there is a major change to the
fundamental scientific technology of the device. The FDA has published a guidance on
this technology and special controls have been established. This change would be best
filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. PMA - Correct answer B. Abbreviated 510(k)
, If a device failure is occurring with greater than expected frequency and investigation
of the problem implicates improper use by the end user, which of the following
typically occurs?
A. The labeling is revised
B. The product is recalled
C. The product is redesigned
D. A "Dear Doctor" letter is issued - Correct answer A. The labeling is revised
The labeling should provide appropriate information for proper use of the product.
Failure of a device manufacturer to notify FDA under paragraph 510(k) of the FD&C Act
before marketing a device:
A. Makes the product misbranded under Section 502 of the Act
B. Introduces an unapproved product into interstate commerce
C. Causes the product to be mislabeled
Update) Questions & Answers 100%
Correct (Verified Solutions) - {Grade A}
A legally marketed device to which equivalence is drawn in a premarketing submission
is known as the:
A. Comparator device
B. Predecessor device
C. Predicate device
D. Substantially equivalent device - Correct answer C. Predicate device
An identification of the legally marketed device to which the submitter claims
equivalence. A legally marketed device to which a new device may be compared for a
determination regarding substantial equivalence is a device that was legally marketed
prior to May 28, 1976, or a device which has been reclassified from class III to class II
or I (the predicate), or a device which has been found to be substantially equivalent
through the 510(k) premarket notification process; 21 CFR 807.100(b). The data
submitted establishes that the device is substantially equivalent to the predicate
,device and contains information, including clinical data if deemed necessary by the
Commissioner, that demonstrates that the device is as safe and as effective as a
legally marketed device.
The QSR includes requirements for Design Controls. All of the following statements
about Design Reviews are true EXCEPT:
A. Mfgers required to maintain procedures to ensure formal reviews occur at
appropriate stages of design and dev
B. Participation at design reviews must include reps of all fxns concerned with the
stage being reviewed.
C. Participation shall include at least one individual who does not have direct
responsibility for stage being reviewed.
D. Results of design review shall be documented in the device history record. - Correct
answer D. Results of design review shall be documented in the device history record.
The results of the design review shall be documented in the device history file (DHF);
see 21 CFR 820.30(e).
,A humanitarian device exemption (HDE) differs from a traditional PMA in that:
A. It does not require compliance with QSR.
B. Non-clinical data are not required.
C. Effectiveness data are not required.
D. Device characteristics are not required. - Correct answer C. Effectiveness data are
not required.
A company wants to modify its device such that there is a major change to the
fundamental scientific technology of the device. The FDA has published a guidance on
this technology and special controls have been established. This change would be best
filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. PMA - Correct answer B. Abbreviated 510(k)
, If a device failure is occurring with greater than expected frequency and investigation
of the problem implicates improper use by the end user, which of the following
typically occurs?
A. The labeling is revised
B. The product is recalled
C. The product is redesigned
D. A "Dear Doctor" letter is issued - Correct answer A. The labeling is revised
The labeling should provide appropriate information for proper use of the product.
Failure of a device manufacturer to notify FDA under paragraph 510(k) of the FD&C Act
before marketing a device:
A. Makes the product misbranded under Section 502 of the Act
B. Introduces an unapproved product into interstate commerce
C. Causes the product to be mislabeled
