DEVICE RAC EXAM QUESTIONS With
correct Answers (A+ GRADED 100%
VERIFIED) 2025/2026
510(k) Premarket Notifications for all of the following medical devices would be
reviewed by CDRH's Office of Device Evaluation except:
A) High Flux Hemodialyzer
B) Blood specimen collection device
C) Piston syringe
D) Cardiopulmonary bypass blood tubing - ANSWER: B
A company wants to modify its device such that there is a major change to the
fundamental scientific technology of the device. The FDA has published a guidance
on this technology and special controls have been established. This change would
be best filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. PMA - ANSWER: B
A company wants to modify its legally marketed device such that the modification
does not affect the intended use or alter the fundamental scientific technology of the
device. If the design outputs of the modified device meet the design input
requirements, this change would be best filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k) - ANSWER: A
A company's competitor is marketing a Class II suture which dissolves during the
third week of use. The company's current product has to be removed by a physician.
However, a change in weaving configuration gives this product the same dissolving
time as the competitor's. When can the company's new suture be marketed?
A. This requires a new 510(k) since significant change in product instructions might
affect efficacy.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change - ANSWER: A
, A handling and storage system for medical devices must always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
C. Procedures for receipt and transfer of product
D. Environmentally controlled areas for products with shelf life - ANSWER: C
A humanitarian device exemption differs from a traditional PMA in that:
A. It does not require compliance with QSR.
B. Non-clinical data are not required.
C. Effectiveness data are not required. - ANSWER: C
A key component of a new device for which a PMA is being prepared is
manufactured by a second company. Without revealing proprietary information to the
finished product manufacturer, how can the component manufacturer make critical
information available to FDA for review?
A) Submit a Device Master File (MAF)
B) File its own PMA
C) Supply the applicable sections of the finished device manufacturer's PMA directly
to FDA
D) Include a certification in the finished device manufacturer's PMA that the
proprietary information meets FDA's requirements - ANSWER: A
A legally marketed device to which equivalence is drawn in a premarketing
submission is known as the:
A. Comparator device
B. Predecessor device
C. Predicate device
D. Substantially equivalent device - ANSWER: C
A manufacturer which of the following must file an IDE before conducting a human
clinical study?
A. A device in commercial distribution before 28 May 1976 when used or
investigated in
accordance with its indications in labeling in effect at that time
B. A device intended solely for veterinary use
C. A custom device being studied for safety and effectiveness in support of
commercial
marketing
D. A device in commercial distribution before 28 May 1976 when used or
investigated in
correct Answers (A+ GRADED 100%
VERIFIED) 2025/2026
510(k) Premarket Notifications for all of the following medical devices would be
reviewed by CDRH's Office of Device Evaluation except:
A) High Flux Hemodialyzer
B) Blood specimen collection device
C) Piston syringe
D) Cardiopulmonary bypass blood tubing - ANSWER: B
A company wants to modify its device such that there is a major change to the
fundamental scientific technology of the device. The FDA has published a guidance
on this technology and special controls have been established. This change would
be best filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. PMA - ANSWER: B
A company wants to modify its legally marketed device such that the modification
does not affect the intended use or alter the fundamental scientific technology of the
device. If the design outputs of the modified device meet the design input
requirements, this change would be best filed as a(n):
A. Special 510(k)
B. Abbreviated 510(k)
C. Traditional 510(k)
D. De novo 510(k) - ANSWER: A
A company's competitor is marketing a Class II suture which dissolves during the
third week of use. The company's current product has to be removed by a physician.
However, a change in weaving configuration gives this product the same dissolving
time as the competitor's. When can the company's new suture be marketed?
A. This requires a new 510(k) since significant change in product instructions might
affect efficacy.
B. After submission in a periodic report
C. After reporting clinical studies in an annual report
D. After submission of labeling change - ANSWER: A
, A handling and storage system for medical devices must always include:
A. Procedures for rotation of stock
B. Separate rooms or cages for release and quarantine products
C. Procedures for receipt and transfer of product
D. Environmentally controlled areas for products with shelf life - ANSWER: C
A humanitarian device exemption differs from a traditional PMA in that:
A. It does not require compliance with QSR.
B. Non-clinical data are not required.
C. Effectiveness data are not required. - ANSWER: C
A key component of a new device for which a PMA is being prepared is
manufactured by a second company. Without revealing proprietary information to the
finished product manufacturer, how can the component manufacturer make critical
information available to FDA for review?
A) Submit a Device Master File (MAF)
B) File its own PMA
C) Supply the applicable sections of the finished device manufacturer's PMA directly
to FDA
D) Include a certification in the finished device manufacturer's PMA that the
proprietary information meets FDA's requirements - ANSWER: A
A legally marketed device to which equivalence is drawn in a premarketing
submission is known as the:
A. Comparator device
B. Predecessor device
C. Predicate device
D. Substantially equivalent device - ANSWER: C
A manufacturer which of the following must file an IDE before conducting a human
clinical study?
A. A device in commercial distribution before 28 May 1976 when used or
investigated in
accordance with its indications in labeling in effect at that time
B. A device intended solely for veterinary use
C. A custom device being studied for safety and effectiveness in support of
commercial
marketing
D. A device in commercial distribution before 28 May 1976 when used or
investigated in
