Page 1 of 315
RAPS ACTUAL PRACTICE EXAM NEWEST
2026/2027 COMPLETE QUESTIONS AND
CORRECT ANSWERS ALREADY GRADED
A+||BRAND NEW PDF!!
1. What is the primary distinction between a medical device
and a drug under U.S. FDA regulations?
A) Devices are regulated by CDER; drugs are regulated by
CDRH
B) Devices achieve their primary intended purpose through
chemical action, while drugs work mechanically
C) Drugs achieve their primary intended purpose through
chemical action, while devices work mechanically
D) There is no functional distinction; classification is based solely
on risk
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Answer: C
Rationale: Under the Federal Food, Drug, and Cosmetic Act
(FD&C Act), a device is defined as an instrument, apparatus, or
machine that does not achieve its primary intended purpose
through chemical action within or on the body. Drugs, in contrast,
achieve their effects through chemical, pharmacological, or
metabolic means. This distinction is fundamental to regulatory
classification.
2. Which U.S. FDA Center is responsible for regulating
biologics such as vaccines and gene therapies?
A) Center for Drug Evaluation and Research (CDER)
B) Center for Biologics Evaluation and Research (CBER)
C) Center for Devices and Radiological Health (CDRH)
D) Center for Veterinary Medicine (CVM)
Answer: B
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Rationale: CBER regulates biological products including vaccines,
blood products, cellular and gene therapies, and allergenics.
While some therapeutic proteins fall under CDER, CBER maintains
jurisdiction over traditional biologics.
3. A company is developing a novel medical device that is
substantially equivalent to a device marketed before May 28,
1976. What is the most appropriate premarket submission
pathway?
A) Premarket Approval (PMA)
B) 510(k) Premarket Notification
C) De Novo Classification Request
D) Investigational Device Exemption (IDE)
Answer: B
Rationale: Section 510(k) of the FD&C Act allows a device to be
cleared for marketing if it is substantially equivalent to a
, Page 4 of 315
predicate device that was legally marketed prior to May 28,
1976 (or to a device that has since been cleared through the
510(k) process). This is the most common pathway for moderate-
risk (Class II) devices.
4. A breakthrough therapy designation granted by FDA
provides which of the following benefits?
A) Expedited review and more frequent guidance from FDA
B) Automatic approval without clinical data
C) Ten years of market exclusivity
D) Waiver of all user fees
Answer: A
Rationale: Breakthrough Therapy designation, established under
the 21st Century Cures Act, provides intensive FDA guidance on
efficient drug development, organizational commitment involving
RAPS ACTUAL PRACTICE EXAM NEWEST
2026/2027 COMPLETE QUESTIONS AND
CORRECT ANSWERS ALREADY GRADED
A+||BRAND NEW PDF!!
1. What is the primary distinction between a medical device
and a drug under U.S. FDA regulations?
A) Devices are regulated by CDER; drugs are regulated by
CDRH
B) Devices achieve their primary intended purpose through
chemical action, while drugs work mechanically
C) Drugs achieve their primary intended purpose through
chemical action, while devices work mechanically
D) There is no functional distinction; classification is based solely
on risk
,Page 2 of 315
Answer: C
Rationale: Under the Federal Food, Drug, and Cosmetic Act
(FD&C Act), a device is defined as an instrument, apparatus, or
machine that does not achieve its primary intended purpose
through chemical action within or on the body. Drugs, in contrast,
achieve their effects through chemical, pharmacological, or
metabolic means. This distinction is fundamental to regulatory
classification.
2. Which U.S. FDA Center is responsible for regulating
biologics such as vaccines and gene therapies?
A) Center for Drug Evaluation and Research (CDER)
B) Center for Biologics Evaluation and Research (CBER)
C) Center for Devices and Radiological Health (CDRH)
D) Center for Veterinary Medicine (CVM)
Answer: B
,Page 3 of 315
Rationale: CBER regulates biological products including vaccines,
blood products, cellular and gene therapies, and allergenics.
While some therapeutic proteins fall under CDER, CBER maintains
jurisdiction over traditional biologics.
3. A company is developing a novel medical device that is
substantially equivalent to a device marketed before May 28,
1976. What is the most appropriate premarket submission
pathway?
A) Premarket Approval (PMA)
B) 510(k) Premarket Notification
C) De Novo Classification Request
D) Investigational Device Exemption (IDE)
Answer: B
Rationale: Section 510(k) of the FD&C Act allows a device to be
cleared for marketing if it is substantially equivalent to a
, Page 4 of 315
predicate device that was legally marketed prior to May 28,
1976 (or to a device that has since been cleared through the
510(k) process). This is the most common pathway for moderate-
risk (Class II) devices.
4. A breakthrough therapy designation granted by FDA
provides which of the following benefits?
A) Expedited review and more frequent guidance from FDA
B) Automatic approval without clinical data
C) Ten years of market exclusivity
D) Waiver of all user fees
Answer: A
Rationale: Breakthrough Therapy designation, established under
the 21st Century Cures Act, provides intensive FDA guidance on
efficient drug development, organizational commitment involving
