US RAC EXAM 2026 STUDY GUIDE
QUESTION SET ACCURATE EVALUATION
MATERIAL
◉ Declaration of Helsinki
Answer: Ethical principles for medical research involving human
subjects. Trials conducted under Good Clinical Practice generally
follow the Declaration of Helsinki.
◉ De Novo Process
Answer: Provides a route to market for medical devices that are 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
Answer: Design History File. Describes a finished device's design.
◉ DHR
Answer: Device History Record. Contains a device's production
history.
,◉ DMEPA
Answer: Division of Medication Error Prevention and Analysis
(CBER)
◉ DMF
Answer: Drug Master File. Submission to FDA that may be used to
provide confidential detailed information about facilities, processes
or articles used in the manufacturing, processing, packaging and
storing of one or more human drugs.
◉ DMR
Answer: Device Master Record. Compilation of records containing a
finished device's procedures and specifications.
◉ Drug
Answer: Any article intended for use in the diagnosis, cure,
mitigation, treatment or prevention of disease in man.
◉ Drug Product
Answer: A finished dosage form (e.g., tablet, capsule, solution, etc.)
that contains an active drug ingredient. It is generally, but not
necessarily, also associated with inactive ingredients. This includes a
finished dosage form that does not contain an active ingredient but
is intended to be used a as placebo.
, ◉ eCTD
Answer: Electronic Common Technical Document
◉ Emergency Use IND
Answer: FDA authorization for shipping a drug for a specific
emergency use for a life-threatening or serious disease for which
there is no alternative treatment.
◉ Establishment Listing and Registration
Answer: In accordance with 21 CFR 807, manufacturers (both
domestic and foreign) and initial distributors (importers) of medical
devices must electronically register their establishments with FDA.
Manufacturers must also list their devices with FDA.
◉ Excipient
Answer: An ingredient contained in a drug formulation that is not a
medicinally active constituent.
◉ Fast Track
Answer: FDA program to facilitate the development and expedite the
review of new drugs intended to treat serious or life-threatening
conditions that demonstrate the potential to address unmet medical
needs. Accelerated NDA review.
QUESTION SET ACCURATE EVALUATION
MATERIAL
◉ Declaration of Helsinki
Answer: Ethical principles for medical research involving human
subjects. Trials conducted under Good Clinical Practice generally
follow the Declaration of Helsinki.
◉ De Novo Process
Answer: Provides a route to market for medical devices that are 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
Answer: Design History File. Describes a finished device's design.
◉ DHR
Answer: Device History Record. Contains a device's production
history.
,◉ DMEPA
Answer: Division of Medication Error Prevention and Analysis
(CBER)
◉ DMF
Answer: Drug Master File. Submission to FDA that may be used to
provide confidential detailed information about facilities, processes
or articles used in the manufacturing, processing, packaging and
storing of one or more human drugs.
◉ DMR
Answer: Device Master Record. Compilation of records containing a
finished device's procedures and specifications.
◉ Drug
Answer: Any article intended for use in the diagnosis, cure,
mitigation, treatment or prevention of disease in man.
◉ Drug Product
Answer: A finished dosage form (e.g., tablet, capsule, solution, etc.)
that contains an active drug ingredient. It is generally, but not
necessarily, also associated with inactive ingredients. This includes a
finished dosage form that does not contain an active ingredient but
is intended to be used a as placebo.
, ◉ eCTD
Answer: Electronic Common Technical Document
◉ Emergency Use IND
Answer: FDA authorization for shipping a drug for a specific
emergency use for a life-threatening or serious disease for which
there is no alternative treatment.
◉ Establishment Listing and Registration
Answer: In accordance with 21 CFR 807, manufacturers (both
domestic and foreign) and initial distributors (importers) of medical
devices must electronically register their establishments with FDA.
Manufacturers must also list their devices with FDA.
◉ Excipient
Answer: An ingredient contained in a drug formulation that is not a
medicinally active constituent.
◉ Fast Track
Answer: FDA program to facilitate the development and expedite the
review of new drugs intended to treat serious or life-threatening
conditions that demonstrate the potential to address unmet medical
needs. Accelerated NDA review.
