R.A.C-Exam -US Self-Assessment
Questions with Guaranteed Pass
Solutions.
Which of the following federal laws includes information about ANDA submissions?
A. Antibiotic Amendments of 1945
B. Durham-Humphrey Amendment of 1951
C. Drug Amendments of 1962
D. Drug Price Competition and Patent Term Restoration Act of 1984 - Answer D. Drug Price
Competition and Patent Term Restoration Act of 1984
This Act permitted manufacturers to use abbreviated NDAs to gain approval for generic versions
of approved drugs whose patents had expired.
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on
primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP - Answer C. CDRH
In this combination of a device and a drug, the primary mode of action is that of the vascular
graft (device). The antibiotic is supportive in this case.
A company wants to modify its legally marketed device such that the modification does not
affect the intended use or alter the fundamental scientific technology of the device. If the
design outputs of the modified device meet the design input requirements, this change would
be best filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k) - Answer A. Special 510(k)
,A Special 510(k) is allowed if a modification to the legally marketed device is being made that
relies on compliance with design controls, including design validation. The incentive provided
for manufacturers to choose this option is that ODE intends to process special 510(k)s within 30
days of receipt. See the CDRH guidance published in 1998 entitled The New 510(k) Paradigm -
Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.
A personal deodorant manufacturer is required to do all of the following EXCEPT:
A. Comply with GMP
B. State the place of business on the label
C. List the quantity of contents on the label
D. Comply with export regulations when exporting product - Answer A. Comply with GMP
Compliance to GMP is recommended, but not required for cosmetics. See the FD&C Act, Section
602(b).
Under the statutory violations, failure to meet 510(k) requirements for a device
that is required to have a 510(k) and is in commercial distribution is considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent - Answer C. Misbranded
A marketed device that needs a 510(k) for commercialization but failed to comply with the
requirements is considered to be Misbranded. See the FD&C Act, 502(o).
A company's competitor is marketing a Class II suture which dissolves during the third week of
use. The company's current product has to be removed by a
physician. However, 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 - Answer A. This requires a new 510(k) since significant
change in product instructions might affect efficacy.
,A new intended use requires a 510(k) clearance.
Which of the following is exempt from GMP/QS regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - Answer D. Component manufacturers
Component manufacturers are excluded from GMP per 21 CFR 820.1(a)(1).
Which of the following changes require FDA approval of NDA supplements before the change is
made?
A. Adding an additional test method
B. Deleting a dye from the drug product
C. Making changes that comply with USP
D. Relaxing the limits for a drug products specification - Answer D. Relaxing the limits for a
drug products specification
Prior FDA approval is required for a noncompendial relaxation of release
specification limits; See 21 CFR 314.70.
All of the following are considered General Controls under the Food, Drug, and Cosmetic Act
EXCEPT:
A. Establishment registration
B. Premarket approval application (PMA)
C. Medical device reporting
D. Premarket notification [510(k)] submission - Answer B. Premarket approval application
(PMA)
Premarket approval application (PMA) is not a general control.
, If the FDA responds to a 510(k) with a NSE letter, the 510(k) applicant has which of the following
options?
A. Resubmit another 510(k) with additional data supporting the claim of SE
B. Petition the FDA for reconsideration of its decision
C. Claim exemption from 510(k) requirements
D. A & B only - Answer D. A & B only
A. Resubmit another 510(k) with additional data supporting the claim of SE
B. Petition the FDA for reconsideration of its decision
Failure of a device manufacturer to notify FDA under paragraph 510(k) of the Federal FD&C Act
before marketing a device that requires such notification:
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
D. Will initiate Compliance Office action to require submission of a PMA - Answer A. Makes
the product misbranded under Section 502 of the act
The product is considered to be misbranded if the product is not cleared through the 510(k)
process. See the federal FD&C Act, Section 502(o). Note: A product is considered adulterated if
the product requires an approved PMA but does not have one.
A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after
treatment with an approved device. This side effect is not listed in the package insert. This event
must be reported by the manufacturer to FDA no later
than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report - Answer C. 30 calendar days
Serious injury must be reported within 30 days; see 21 CFR 803.50(a).
Questions with Guaranteed Pass
Solutions.
Which of the following federal laws includes information about ANDA submissions?
A. Antibiotic Amendments of 1945
B. Durham-Humphrey Amendment of 1951
C. Drug Amendments of 1962
D. Drug Price Competition and Patent Term Restoration Act of 1984 - Answer D. Drug Price
Competition and Patent Term Restoration Act of 1984
This Act permitted manufacturers to use abbreviated NDAs to gain approval for generic versions
of approved drugs whose patents had expired.
Which division would have primary jurisdiction over a vascular graft with an antibiotic based on
primary mode of action?
A. CDER
B. CBER
C. CDRH
D. OCP - Answer C. CDRH
In this combination of a device and a drug, the primary mode of action is that of the vascular
graft (device). The antibiotic is supportive in this case.
A company wants to modify its legally marketed device such that the modification does not
affect the intended use or alter the fundamental scientific technology of the device. If the
design outputs of the modified device meet the design input requirements, this change would
be best filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k) - Answer A. Special 510(k)
,A Special 510(k) is allowed if a modification to the legally marketed device is being made that
relies on compliance with design controls, including design validation. The incentive provided
for manufacturers to choose this option is that ODE intends to process special 510(k)s within 30
days of receipt. See the CDRH guidance published in 1998 entitled The New 510(k) Paradigm -
Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.
A personal deodorant manufacturer is required to do all of the following EXCEPT:
A. Comply with GMP
B. State the place of business on the label
C. List the quantity of contents on the label
D. Comply with export regulations when exporting product - Answer A. Comply with GMP
Compliance to GMP is recommended, but not required for cosmetics. See the FD&C Act, Section
602(b).
Under the statutory violations, failure to meet 510(k) requirements for a device
that is required to have a 510(k) and is in commercial distribution is considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent - Answer C. Misbranded
A marketed device that needs a 510(k) for commercialization but failed to comply with the
requirements is considered to be Misbranded. See the FD&C Act, 502(o).
A company's competitor is marketing a Class II suture which dissolves during the third week of
use. The company's current product has to be removed by a
physician. However, 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 - Answer A. This requires a new 510(k) since significant
change in product instructions might affect efficacy.
,A new intended use requires a 510(k) clearance.
Which of the following is exempt from GMP/QS regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - Answer D. Component manufacturers
Component manufacturers are excluded from GMP per 21 CFR 820.1(a)(1).
Which of the following changes require FDA approval of NDA supplements before the change is
made?
A. Adding an additional test method
B. Deleting a dye from the drug product
C. Making changes that comply with USP
D. Relaxing the limits for a drug products specification - Answer D. Relaxing the limits for a
drug products specification
Prior FDA approval is required for a noncompendial relaxation of release
specification limits; See 21 CFR 314.70.
All of the following are considered General Controls under the Food, Drug, and Cosmetic Act
EXCEPT:
A. Establishment registration
B. Premarket approval application (PMA)
C. Medical device reporting
D. Premarket notification [510(k)] submission - Answer B. Premarket approval application
(PMA)
Premarket approval application (PMA) is not a general control.
, If the FDA responds to a 510(k) with a NSE letter, the 510(k) applicant has which of the following
options?
A. Resubmit another 510(k) with additional data supporting the claim of SE
B. Petition the FDA for reconsideration of its decision
C. Claim exemption from 510(k) requirements
D. A & B only - Answer D. A & B only
A. Resubmit another 510(k) with additional data supporting the claim of SE
B. Petition the FDA for reconsideration of its decision
Failure of a device manufacturer to notify FDA under paragraph 510(k) of the Federal FD&C Act
before marketing a device that requires such notification:
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
D. Will initiate Compliance Office action to require submission of a PMA - Answer A. Makes
the product misbranded under Section 502 of the act
The product is considered to be misbranded if the product is not cleared through the 510(k)
process. See the federal FD&C Act, Section 502(o). Note: A product is considered adulterated if
the product requires an approved PMA but does not have one.
A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after
treatment with an approved device. This side effect is not listed in the package insert. This event
must be reported by the manufacturer to FDA no later
than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report - Answer C. 30 calendar days
Serious injury must be reported within 30 days; see 21 CFR 803.50(a).
