RAC (Device) Verified Multiple Choice and
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. Under whose authority can an imported drug, device or biologic be detained or
refused entry into the US?
A. US Department of Agriculture.
B. US Customs.
C. FDA.
D. FBI. - ANSWER B. US Customs.
US Customs is the only US agency that has been granted authority to detain or
refuse entry of imported products.
2. Which of the following is NOT true of an Advisory Committee?
A. Advisory Committee meetings can include an oral presentation from a patient
advocacy group.
B. Advisory Committee members are selected without regard to race, ethnicity,
sex, age or religion.
C. Advisory Committees provide advice to FDA on safety and effectiveness of
drugs.
,D. Advisory Committees recommend whether a drug should be approved and do
not provide advice on product labeling or clinical trial design. - ANSWER D.
Advisory Committees recommend whether a drug should be approved and do not
provide advice on product labeling or clinical trial design.
The Advisory Committee can review and make recommendations on any matter
before the FDA. 21 CFR 14.1(a)(1). The Advisory Committee advises for human
prescription drugs "on the safety and effectiveness, including the labeling and
advertising." 21 CFR 14.160(a).
3. An IRB will NOT review:
A. Risks and benefits of the proposed research.
B. Risks and benefits of alternative therapies.
C. Prospective informed consent document.
D. Provisions to protect the privacy of subjects. - ANSWER B. Risks and
benefits of alternative therapies.
FDA regulations do not require an IRB to assess the risks or benefits of
alternatives.
4. The Freedom of Information Act allows a manufacturer to:
A. Make claims about a product already commercially available.
B. Obtain QC methods on a competitor's product.
C. Obtain the Drug/Device Master File of a competitor's product.
D. Obtain public documents on another manufacturer's product. - ANSWER
D. Obtain public documents on another manufacturer's product.
, Public documents on another company's product are available through a written
quest to the FOIA office.
5. Removal of a distributed product for a reason NOT subject to legal action by
FDA is known as:
A. Product recall.
B. Stock recovery.
C. Market withdrawal.
D. Corrective action. - ANSWER C. Market withdrawal.
Market withdrawal applies when a firm removes or corrects a distributed product
which involves a minor violation that would not be subject to legal action by the
FDA, e.g. normal stock rotation practices, routine equipment adjustments and
repairs 21 CFR 7.3(j).
6. Due to mechanical failure, a product line has remained in process for five days
over the time limit established in the company's SOPs. Which of the following
should be done first?
A. Reject the product since the time limit has been exceeded.
B. Proceed with processing and quarantine the product.
C. Complete the manufacturing process and ship the product.
D. Have the Regulatory Affairs department investigate and prepare a deviation
report and document all events. - ANSWER B. Proceed with processing and
quarantine the product.
Conceptual Actual Frequently Tested Exam
Questions With Reviewed 100%
Correct Detailed Answers
Guaranteed Pass!!Current Update!!
1. Under whose authority can an imported drug, device or biologic be detained or
refused entry into the US?
A. US Department of Agriculture.
B. US Customs.
C. FDA.
D. FBI. - ANSWER B. US Customs.
US Customs is the only US agency that has been granted authority to detain or
refuse entry of imported products.
2. Which of the following is NOT true of an Advisory Committee?
A. Advisory Committee meetings can include an oral presentation from a patient
advocacy group.
B. Advisory Committee members are selected without regard to race, ethnicity,
sex, age or religion.
C. Advisory Committees provide advice to FDA on safety and effectiveness of
drugs.
,D. Advisory Committees recommend whether a drug should be approved and do
not provide advice on product labeling or clinical trial design. - ANSWER D.
Advisory Committees recommend whether a drug should be approved and do not
provide advice on product labeling or clinical trial design.
The Advisory Committee can review and make recommendations on any matter
before the FDA. 21 CFR 14.1(a)(1). The Advisory Committee advises for human
prescription drugs "on the safety and effectiveness, including the labeling and
advertising." 21 CFR 14.160(a).
3. An IRB will NOT review:
A. Risks and benefits of the proposed research.
B. Risks and benefits of alternative therapies.
C. Prospective informed consent document.
D. Provisions to protect the privacy of subjects. - ANSWER B. Risks and
benefits of alternative therapies.
FDA regulations do not require an IRB to assess the risks or benefits of
alternatives.
4. The Freedom of Information Act allows a manufacturer to:
A. Make claims about a product already commercially available.
B. Obtain QC methods on a competitor's product.
C. Obtain the Drug/Device Master File of a competitor's product.
D. Obtain public documents on another manufacturer's product. - ANSWER
D. Obtain public documents on another manufacturer's product.
, Public documents on another company's product are available through a written
quest to the FOIA office.
5. Removal of a distributed product for a reason NOT subject to legal action by
FDA is known as:
A. Product recall.
B. Stock recovery.
C. Market withdrawal.
D. Corrective action. - ANSWER C. Market withdrawal.
Market withdrawal applies when a firm removes or corrects a distributed product
which involves a minor violation that would not be subject to legal action by the
FDA, e.g. normal stock rotation practices, routine equipment adjustments and
repairs 21 CFR 7.3(j).
6. Due to mechanical failure, a product line has remained in process for five days
over the time limit established in the company's SOPs. Which of the following
should be done first?
A. Reject the product since the time limit has been exceeded.
B. Proceed with processing and quarantine the product.
C. Complete the manufacturing process and ship the product.
D. Have the Regulatory Affairs department investigate and prepare a deviation
report and document all events. - ANSWER B. Proceed with processing and
quarantine the product.
