US RAC Exam Prep 2026 \NEWEST VERSION WITH
COMPLETE QUESTIONS AND ACCURATE DETAILED
ANSWERS \VERIFIED 100% ALREADY GRADED A+
LATEST UPDATE 2025-2026
CBER Center for Biologics Evaluation and Research
CDER Center for Drug Evaluation and Research
CDRH Center for Devices and Radiological Health
Document used to inform a potential subject of the
Consent Form (CF or ICF)
risks and benefits of a clinical trial per the Declaration
of Helsinki.
Required by certain countries to prove that an exported
Certificate to Foreign
Government (CFG) product can be legally marketed in the US.
CFR Code of Federal Regulations
Class I Device Low-risk device requiring general controls to ensure safety
and effectiveness.
Requires general and special controls to ensure safety and
effectiveness. Special controls may include mandatory
Class II Device performance standards, patient registries for
implantable devices and postmarket surveillance. Requires
510(k), unless exempted; may require clinical trials.
Requires general controls, special controls and premarket
approval (PMA); includes devices that are life-sustaining,
Class III Device life-supporting or pose significant potential for risk to
patient, or are not substantially equivalent to Class I or
Class II devices. PMAs almost always require clinical trials.
, Devices that receive marketing permission through the
Clearance 510(k) process based on demonstrating substantial
equivalence to a pre-amendment device or another
device reviewed under section 510(k) of the FD&C
Act.
FDA order to delay proposed clinical investigation or
Clinical Hold
suspend an ongoing investigation.
Defined in 21 CFR 3.2(e) as a combination of two or
more different types of regulated products, i.e.:
- a drug and a device
Combination Product - a device and a biological product
- a drug and a biological product
- a drug, a device and a biological product
Any distribution of a device intended for human use,
Commercial Distribution which is offered for sale but does not include: internal
or interplant transfer within the same parent, subsidiary
or affiliate company any device with an approved
exemption for investigational use.
Requires the research institution's IRB to ensure that
Common Rule
each research protocol contains adequate provisions to
protect a subject during the course of the study.
Any written, electronic or oral communication alleging
Complaint deficiencies related to a
product's identity, quality, durability, reliability, safety,
effectiveness or performance after release for
distribution.
Any ingredient or part intended for use in the
Component manufacture of a drug, device, cosmetic, biologic or IVD
product, including those that may not appear in the
finished product.
Articles intended to be rubbed, poured, sprinkled or
sprayed on, introduced into or otherwise applied to the
Cosmetic
human body or any part thereof for cleansing,
beautifying, promoting attractiveness or altering
appearance; and, articles intended for use as a
component of any such article; except that such
term shall not include soap.
, CPSC Consumer Product Safety Commision
Communicates FDA's decision to a drug company that
Complete Response (CR) its new drug application (NDA) or abbreviation new
Letter
drug application (ANDA) to market a new or generic
drug will not be approved in its present form.
Ethical principles for medical research involving human
Declaration of Helsinki
subjects. Trials conducted under Good Clinical Practice
generally follow the Declaration of Helsinki.
Provides a route to market for medical devices that are
De Novo Process low to moderate risk, but that have been classified in
Class III because FDA has found them to be "not
substantially equivalent" (NSE) to legally marketed
predicate devices.
DHF Design History File. Describes a finished device's design.
DHR Device History Record. Contains a device's production history.
DMEPA Division of Medication Error Prevention and Analysis (CBER)
COMPLETE QUESTIONS AND ACCURATE DETAILED
ANSWERS \VERIFIED 100% ALREADY GRADED A+
LATEST UPDATE 2025-2026
CBER Center for Biologics Evaluation and Research
CDER Center for Drug Evaluation and Research
CDRH Center for Devices and Radiological Health
Document used to inform a potential subject of the
Consent Form (CF or ICF)
risks and benefits of a clinical trial per the Declaration
of Helsinki.
Required by certain countries to prove that an exported
Certificate to Foreign
Government (CFG) product can be legally marketed in the US.
CFR Code of Federal Regulations
Class I Device Low-risk device requiring general controls to ensure safety
and effectiveness.
Requires general and special controls to ensure safety and
effectiveness. Special controls may include mandatory
Class II Device performance standards, patient registries for
implantable devices and postmarket surveillance. Requires
510(k), unless exempted; may require clinical trials.
Requires general controls, special controls and premarket
approval (PMA); includes devices that are life-sustaining,
Class III Device life-supporting or pose significant potential for risk to
patient, or are not substantially equivalent to Class I or
Class II devices. PMAs almost always require clinical trials.
, Devices that receive marketing permission through the
Clearance 510(k) process based on demonstrating substantial
equivalence to a pre-amendment device or another
device reviewed under section 510(k) of the FD&C
Act.
FDA order to delay proposed clinical investigation or
Clinical Hold
suspend an ongoing investigation.
Defined in 21 CFR 3.2(e) as a combination of two or
more different types of regulated products, i.e.:
- a drug and a device
Combination Product - a device and a biological product
- a drug and a biological product
- a drug, a device and a biological product
Any distribution of a device intended for human use,
Commercial Distribution which is offered for sale but does not include: internal
or interplant transfer within the same parent, subsidiary
or affiliate company any device with an approved
exemption for investigational use.
Requires the research institution's IRB to ensure that
Common Rule
each research protocol contains adequate provisions to
protect a subject during the course of the study.
Any written, electronic or oral communication alleging
Complaint deficiencies related to a
product's identity, quality, durability, reliability, safety,
effectiveness or performance after release for
distribution.
Any ingredient or part intended for use in the
Component manufacture of a drug, device, cosmetic, biologic or IVD
product, including those that may not appear in the
finished product.
Articles intended to be rubbed, poured, sprinkled or
sprayed on, introduced into or otherwise applied to the
Cosmetic
human body or any part thereof for cleansing,
beautifying, promoting attractiveness or altering
appearance; and, articles intended for use as a
component of any such article; except that such
term shall not include soap.
, CPSC Consumer Product Safety Commision
Communicates FDA's decision to a drug company that
Complete Response (CR) its new drug application (NDA) or abbreviation new
Letter
drug application (ANDA) to market a new or generic
drug will not be approved in its present form.
Ethical principles for medical research involving human
Declaration of Helsinki
subjects. Trials conducted under Good Clinical Practice
generally follow the Declaration of Helsinki.
Provides a route to market for medical devices that are
De Novo Process low to moderate risk, but that have been classified in
Class III because FDA has found them to be "not
substantially equivalent" (NSE) to legally marketed
predicate devices.
DHF Design History File. Describes a finished device's design.
DHR Device History Record. Contains a device's production history.
DMEPA Division of Medication Error Prevention and Analysis (CBER)
