DEVICE RAC EXAM QUESTIONSWITH
CORRECT ANSWERS GRADED A
DOWNLOAD TO SCORE A
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
accordance with its indications in labeling in effect at that time and intended solely for
veterinary use - Answer -C
A medical device is refused entry to the US. All of the following may be reasons for refusal EXCEPT for
the lack of:
A. Establishment registration by the foreign manufacturer
B. Medical device listing by the foreign manufacturer
C. Substantially equivalent letter from FDA
D. Establishment registration by the initial distributor - Answer -A
A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment
with an approved device. This side effect is not listed in the package insert. This event must be reported
by the manufacturer to FDA no later than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report - Answer -C
According to the QSR, Design Inputs are best described by the following:
A) The Operator's Manual and instructions on how to use the device
B) The Instructions For Use (IFU) of the device
C) Marketing claims and features that are required for the device
CORRECT ANSWERS GRADED A
DOWNLOAD TO SCORE A
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
accordance with its indications in labeling in effect at that time and intended solely for
veterinary use - Answer -C
A medical device is refused entry to the US. All of the following may be reasons for refusal EXCEPT for
the lack of:
A. Establishment registration by the foreign manufacturer
B. Medical device listing by the foreign manufacturer
C. Substantially equivalent letter from FDA
D. Establishment registration by the initial distributor - Answer -A
A physician reports to a manufacturer that a patient was hospitalized with acute sepsis after treatment
with an approved device. This side effect is not listed in the package insert. This event must be reported
by the manufacturer to FDA no later than:
A. 5 calendar days
B. 15 calendar days
C. 30 calendar days
D. The next quarterly or annual report - Answer -C
According to the QSR, Design Inputs are best described by the following:
A) The Operator's Manual and instructions on how to use the device
B) The Instructions For Use (IFU) of the device
C) Marketing claims and features that are required for the device
