DEVICE RAC EXAM 2024 | Questions with
100% Correct Answers | Verified | Latest
Update 2024| Graded A+ ACTUAL EXAM TEST
BANK ALL QUESTIONS AND CORRECT DETAILED
ANSWERS WITH RATIONALES (VERIFIED
ANSWERS) |ALREADY GRADED A+||NEWEST
VERSION
A regulatory affairs professional is determining which FDA
center has primary jurisdiction over a vascular graft that
incorporates an antibiotic based on its primary mode of action.
Which center should the professional identify as having primary
jurisdiction?
a. CDER (Center for Drug Evaluation and Research)
b. CBER (Center for Biologics Evaluation and Research)
c. CDRH (Center for Devices and Radiological Health)
d. OCP (Office of Combination Products)
,✔️ Correct Answer: C
Rationale: CDRH has primary jurisdiction over a vascular graft
with an antibiotic when the primary mode of action is that of a
device. The assignment of combination products to a lead
center is based on the primary mode of action (PMOA). When a
device provides the primary therapeutic effect, CDRH assumes
jurisdiction even when the product contains a drug or biologic
component. Option A is incorrect because CDER primarily
regulates drugs. Option B is incorrect because CBER regulates
biologics and certain biological devices. Option D is incorrect
because OCP assigns jurisdiction but does not have primary
review authority for combination products.
A regulatory professional is reviewing statutory violations for
medical devices. Failure to meet 510(k) requirements for a
device that is required to have a 510(k) and is in commercial
distribution is considered which type of violation?
a. Adulteration
b. Improper use
c. Misbranded
d. Fraudulent
✔️ Correct Answer: C
Rationale: Under the FD&C Act, failure to meet 510(k)
requirements for a device that requires premarket notification
and is in commercial distribution constitutes misbranding. The
device is considered misbranded because it lacks proper
,premarket clearance. Option A is incorrect because adulteration
involves issues with manufacturing, quality, or contamination.
Option B is incorrect because improper use is not a statutory
violation category. Option D is incorrect because fraudulent
would require intentional deception beyond mere failure to
meet requirements.
A regulatory professional is investigating a device failure that is
occurring with greater than expected frequency. Investigation of
the problem implicates improper use by the end user. Which
action typically occurs in this situation?
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
Rationale: When device failure is traced to improper use by the
end user, the most common corrective action is revision of the
labeling to provide clearer instructions, warnings, or
contraindications. This addresses the root cause without
requiring product redesign or recall. Option B is incorrect
because a recall is typically reserved for significant safety issues
involving the device itself. Option C is incorrect because
redesign addresses device-related issues, not user-related
issues. Option D is incorrect because while "Dear Doctor" letters
may be used, labeling revision is the primary action.
, A regulatory professional is advising a company whose
competitor markets a Class II suture that dissolves during the
third week of use. The company's current product requires
removal by a physician. A change in weaving configuration gives
this product the same dissolving time as the competitor's.
When can the company's new suture be marketed?
a. This requires a new 510(k) since significant change in product
instructions might affect efficacy
b. After submission in a periodic report
c. After reporting clinical studies in an annual report
d. After submission of labeling change
✔️ Correct Answer: A
Rationale: A change in weaving configuration that alters the
dissolving time of the suture represents a significant change
that could affect the device's efficacy and performance. This
modification requires a new 510(k) submission because the
change affects the device's intended use or fundamental
performance characteristics. Option B is incorrect because
periodic reports are not appropriate for significant device
modifications. Option C is incorrect because clinical studies in
annual reports do not authorize marketing changes. Option D is
incorrect because labeling changes alone are insufficient for
significant product modifications.
100% Correct Answers | Verified | Latest
Update 2024| Graded A+ ACTUAL EXAM TEST
BANK ALL QUESTIONS AND CORRECT DETAILED
ANSWERS WITH RATIONALES (VERIFIED
ANSWERS) |ALREADY GRADED A+||NEWEST
VERSION
A regulatory affairs professional is determining which FDA
center has primary jurisdiction over a vascular graft that
incorporates an antibiotic based on its primary mode of action.
Which center should the professional identify as having primary
jurisdiction?
a. CDER (Center for Drug Evaluation and Research)
b. CBER (Center for Biologics Evaluation and Research)
c. CDRH (Center for Devices and Radiological Health)
d. OCP (Office of Combination Products)
,✔️ Correct Answer: C
Rationale: CDRH has primary jurisdiction over a vascular graft
with an antibiotic when the primary mode of action is that of a
device. The assignment of combination products to a lead
center is based on the primary mode of action (PMOA). When a
device provides the primary therapeutic effect, CDRH assumes
jurisdiction even when the product contains a drug or biologic
component. Option A is incorrect because CDER primarily
regulates drugs. Option B is incorrect because CBER regulates
biologics and certain biological devices. Option D is incorrect
because OCP assigns jurisdiction but does not have primary
review authority for combination products.
A regulatory professional is reviewing statutory violations for
medical devices. Failure to meet 510(k) requirements for a
device that is required to have a 510(k) and is in commercial
distribution is considered which type of violation?
a. Adulteration
b. Improper use
c. Misbranded
d. Fraudulent
✔️ Correct Answer: C
Rationale: Under the FD&C Act, failure to meet 510(k)
requirements for a device that requires premarket notification
and is in commercial distribution constitutes misbranding. The
device is considered misbranded because it lacks proper
,premarket clearance. Option A is incorrect because adulteration
involves issues with manufacturing, quality, or contamination.
Option B is incorrect because improper use is not a statutory
violation category. Option D is incorrect because fraudulent
would require intentional deception beyond mere failure to
meet requirements.
A regulatory professional is investigating a device failure that is
occurring with greater than expected frequency. Investigation of
the problem implicates improper use by the end user. Which
action typically occurs in this situation?
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
Rationale: When device failure is traced to improper use by the
end user, the most common corrective action is revision of the
labeling to provide clearer instructions, warnings, or
contraindications. This addresses the root cause without
requiring product redesign or recall. Option B is incorrect
because a recall is typically reserved for significant safety issues
involving the device itself. Option C is incorrect because
redesign addresses device-related issues, not user-related
issues. Option D is incorrect because while "Dear Doctor" letters
may be used, labeling revision is the primary action.
, A regulatory professional is advising a company whose
competitor markets a Class II suture that dissolves during the
third week of use. The company's current product requires
removal by a physician. A change in weaving configuration gives
this product the same dissolving time as the competitor's.
When can the company's new suture be marketed?
a. This requires a new 510(k) since significant change in product
instructions might affect efficacy
b. After submission in a periodic report
c. After reporting clinical studies in an annual report
d. After submission of labeling change
✔️ Correct Answer: A
Rationale: A change in weaving configuration that alters the
dissolving time of the suture represents a significant change
that could affect the device's efficacy and performance. This
modification requires a new 510(k) submission because the
change affects the device's intended use or fundamental
performance characteristics. Option B is incorrect because
periodic reports are not appropriate for significant device
modifications. Option C is incorrect because clinical studies in
annual reports do not authorize marketing changes. Option D is
incorrect because labeling changes alone are insufficient for
significant product modifications.
