RAC PRACTICE TEST 2026 QUESTIONS WITH
CORRECT ANSWERS
◉ What is one difference between a device trial and a drug
trial?(7:1). Answer: Form FDA 1572 is required for a drug clinical
trial but not a device
◉ List three regulations that are applicable to both drug and device
clinical trials?(7:2). Answer: 21 CFR Parts 50, 54 and 56
◉ List at least two criteria that distinguish the Privacy Rule from the
Common Rule?(7:3). Answer: The Privacy Rule applies to a covered
entity's use or disclosure of PHI, for any research purposes
regardless of funding or what agency has regulatory authory over
the research. Under the Common Rule, the scope of the FDA
Protection of Human Subject Regulations applies only to research
over which FDA has jurisdiction, primarily research involving
investigational products.
◉ Does the Quality System Regulation apply to drugs or
devices?(8:1). Answer: Devices
◉ Does the clinical trial database apply to drugs or devices? (8:2).
Answer: Drugs
,◉ The IRB regulations codified in 21 CFR Part 50 apply only to
drugs. True or False?(8:3). Answer: False. the regulations apply to
both
◉ Name at least three states that have neither clinical trial
legislation nor clinical trial insurance legislation.(8:4). Answer: AL,
AK, AR, HI, ID, IA, KS, and MS
◉ What is GMP?(9:1). Answer: Good Manufacturing Practice or GMP
is a term that is recognized worldwide for the control and
management of manufacturing and quality control testing of foods,
pharmaceutical products and medical devices. Drug GMPs are a set
of regulations that establish minimum requirements for the
methods, facilities and controls used in the manufacturing,
processing , packaging or holding of a drug product. The medical
device GMP is identified as the Quaity System Regulation (QSR).
◉ True or False: GMP is required for both commercial and clinical
materials include Phase 1,2, and 3.(9:2). Answer: True, although
Phase 1 materials are regulated through well-controlled process and
documents.
◉ True or False: A drug or device is deemed adulterated if it was not
made in accordance with GMPs.(9:3). Answer: True.
,◉ What are the key differences between the device quality system
(QSR and drug quality system?(10:1). Answer: The key differences of
the device quality system (QSR) from drug GMPs are management
responsibility, quality plan, corrective/preventive action, design
controls and purchasing control.
◉ True or False: QSR or device GMP is not required for
manufacturing of device components or parts.(10:2). Answer: True
◉ Under whose authority can an imported device (drug or biologic)
be detained or refused entry into the US?
a) Department of Agriculture
b) US Customs
c) FDA
d) FBI(11:1). Answer: B: US Customs is the only US agency that has
been granted authority to detain or refuse entry of imported
products.
◉ Which act grants FDA the authority to implement regulations
requiring medical devices to display a Unique Device Identification
(UDI)?
a) Safe Medical Devices Act of 1990
, b) Medical Device User Fee and Modernization Act of 2002
c) Food and Drug Administration Amendments Act of 2007
d) Food and Drug Administration Modernization Act of 1997(11:2).
Answer: C: Food and Drug Administration Amendments Act of 2007
◉ True or False: Since recall actions are voluntary under 21 CFR 7,
there is no need to report removal or correction of a product that
presents a serious health hazard or involves user error.(11:3).
Answer: False
◉ True or False: Reporting a recall action to FDA is mandatory if the
action involves:a) market withdrawalb) user error posing a serious
health riskc) routine servicingd) serious health riske) a and cf) b
and dg) all of the above(11:4). Answer: F: b-User error posing a
serious health risk and d-serious health risk
◉ What filing category is a move to a different manufacturing site
for secondary packaging where a satisfactory CGMP inspection
exists?(11:5). Answer: Annual Report
◉ True or False: CGMPs do not apply to active pharmaceutical
ingredient manufacturers.(11:6). Answer: False
CORRECT ANSWERS
◉ What is one difference between a device trial and a drug
trial?(7:1). Answer: Form FDA 1572 is required for a drug clinical
trial but not a device
◉ List three regulations that are applicable to both drug and device
clinical trials?(7:2). Answer: 21 CFR Parts 50, 54 and 56
◉ List at least two criteria that distinguish the Privacy Rule from the
Common Rule?(7:3). Answer: The Privacy Rule applies to a covered
entity's use or disclosure of PHI, for any research purposes
regardless of funding or what agency has regulatory authory over
the research. Under the Common Rule, the scope of the FDA
Protection of Human Subject Regulations applies only to research
over which FDA has jurisdiction, primarily research involving
investigational products.
◉ Does the Quality System Regulation apply to drugs or
devices?(8:1). Answer: Devices
◉ Does the clinical trial database apply to drugs or devices? (8:2).
Answer: Drugs
,◉ The IRB regulations codified in 21 CFR Part 50 apply only to
drugs. True or False?(8:3). Answer: False. the regulations apply to
both
◉ Name at least three states that have neither clinical trial
legislation nor clinical trial insurance legislation.(8:4). Answer: AL,
AK, AR, HI, ID, IA, KS, and MS
◉ What is GMP?(9:1). Answer: Good Manufacturing Practice or GMP
is a term that is recognized worldwide for the control and
management of manufacturing and quality control testing of foods,
pharmaceutical products and medical devices. Drug GMPs are a set
of regulations that establish minimum requirements for the
methods, facilities and controls used in the manufacturing,
processing , packaging or holding of a drug product. The medical
device GMP is identified as the Quaity System Regulation (QSR).
◉ True or False: GMP is required for both commercial and clinical
materials include Phase 1,2, and 3.(9:2). Answer: True, although
Phase 1 materials are regulated through well-controlled process and
documents.
◉ True or False: A drug or device is deemed adulterated if it was not
made in accordance with GMPs.(9:3). Answer: True.
,◉ What are the key differences between the device quality system
(QSR and drug quality system?(10:1). Answer: The key differences of
the device quality system (QSR) from drug GMPs are management
responsibility, quality plan, corrective/preventive action, design
controls and purchasing control.
◉ True or False: QSR or device GMP is not required for
manufacturing of device components or parts.(10:2). Answer: True
◉ Under whose authority can an imported device (drug or biologic)
be detained or refused entry into the US?
a) Department of Agriculture
b) US Customs
c) FDA
d) FBI(11:1). Answer: B: US Customs is the only US agency that has
been granted authority to detain or refuse entry of imported
products.
◉ Which act grants FDA the authority to implement regulations
requiring medical devices to display a Unique Device Identification
(UDI)?
a) Safe Medical Devices Act of 1990
, b) Medical Device User Fee and Modernization Act of 2002
c) Food and Drug Administration Amendments Act of 2007
d) Food and Drug Administration Modernization Act of 1997(11:2).
Answer: C: Food and Drug Administration Amendments Act of 2007
◉ True or False: Since recall actions are voluntary under 21 CFR 7,
there is no need to report removal or correction of a product that
presents a serious health hazard or involves user error.(11:3).
Answer: False
◉ True or False: Reporting a recall action to FDA is mandatory if the
action involves:a) market withdrawalb) user error posing a serious
health riskc) routine servicingd) serious health riske) a and cf) b
and dg) all of the above(11:4). Answer: F: b-User error posing a
serious health risk and d-serious health risk
◉ What filing category is a move to a different manufacturing site
for secondary packaging where a satisfactory CGMP inspection
exists?(11:5). Answer: Annual Report
◉ True or False: CGMPs do not apply to active pharmaceutical
ingredient manufacturers.(11:6). Answer: False
