DEVICE RAC ACTUAL EXAM STUDY
GUIDE WITH 100% CORRECT
ANSWERS
1. FDA pathways for medical device approval - ANSWER 510(k), PMA, and
De Novo
2. De Novo pathway - ANSWER For novel, low-to-moderate risk devices
with no predicate.
3. 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
4. Under the statutory violations, failure to meet 510(k) requirements for a
device that is required to have a 510(k) and is in commercial distribution is
considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent - ANSWER C
,5. You have just been hired as Director of Regulatory Affairs at a contract
sterilizer from a similar position at a surgical instrument manufacturer and
are reviewing your firms' records. You haven't come across any device
listing forms for the devices your firm sterilizes that are commercially
available in the U.S. Which of the following responses is correct?
A) Contact FDA to request a large number of Device Listing
forms and assign a member of your staff to begin completing
a form for each device your firm sterilizes.
B) Exclude devices from foreign manufacturers from the list
being prepared above.
C) Find something else to worry about, contract sterilizers are not
required to submit Device Listing forms for the devices they
manufacture. - ANSWER C
6. The MDR regulations require that which of the following groups are not
required to notify FDA if they become aware of information required to be
reported.
A) Manufacturers
B) Distributors
C) Initial importers
D) User facilities - ANSWER B
7. Which of the following conditions may be expected to lead to a field recall
action?
A) Market Withdrawal for correction or removal of distributed
devices involving no violation or minor violation of FD&C
Act
, B) Physical removal of device from point of use to other location
for repair, modification, adjustment, relabeling, destruction, or
inspection
C) Stock Recovery of a device has not left direct control of
manufacturer
D) Routine servicing - ANSWER B
8. When FDA declares a device from a 510(k) application to be Not
Substantially Equivalent (NSE) and requires a PMA. What is the most
practicable first option for a company at this stage?
A) File a PMA immediately
B) Petition CDRH to downclassify the device
C) Resubmit a 510(k) with new data to demonstrate the device is
at least as safe and effective as the predicate.
D) Submit this product for approval in Europe - ANSWER C
9. The Medical Device User Fee and Modernization Act of 2002 enacted all
the following except:
A) User fees for premarket reviews
B) Office of Combination Products
C) Prescription Drug User Fee Act (PDUFA) renewal for five
additional years - ANSWER C
10.What is a major difference between an HDE and a PMA application?
A) Application form and content
B) Labeling requirements
C) Supplemental applications
D) Effectiveness requirements - ANSWER D
11.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
GUIDE WITH 100% CORRECT
ANSWERS
1. FDA pathways for medical device approval - ANSWER 510(k), PMA, and
De Novo
2. De Novo pathway - ANSWER For novel, low-to-moderate risk devices
with no predicate.
3. 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
4. Under the statutory violations, failure to meet 510(k) requirements for a
device that is required to have a 510(k) and is in commercial distribution is
considered to be:
A. Adulteration.
B. Improper use
C. Misbranded
D. Fraudulent - ANSWER C
,5. You have just been hired as Director of Regulatory Affairs at a contract
sterilizer from a similar position at a surgical instrument manufacturer and
are reviewing your firms' records. You haven't come across any device
listing forms for the devices your firm sterilizes that are commercially
available in the U.S. Which of the following responses is correct?
A) Contact FDA to request a large number of Device Listing
forms and assign a member of your staff to begin completing
a form for each device your firm sterilizes.
B) Exclude devices from foreign manufacturers from the list
being prepared above.
C) Find something else to worry about, contract sterilizers are not
required to submit Device Listing forms for the devices they
manufacture. - ANSWER C
6. The MDR regulations require that which of the following groups are not
required to notify FDA if they become aware of information required to be
reported.
A) Manufacturers
B) Distributors
C) Initial importers
D) User facilities - ANSWER B
7. Which of the following conditions may be expected to lead to a field recall
action?
A) Market Withdrawal for correction or removal of distributed
devices involving no violation or minor violation of FD&C
Act
, B) Physical removal of device from point of use to other location
for repair, modification, adjustment, relabeling, destruction, or
inspection
C) Stock Recovery of a device has not left direct control of
manufacturer
D) Routine servicing - ANSWER B
8. When FDA declares a device from a 510(k) application to be Not
Substantially Equivalent (NSE) and requires a PMA. What is the most
practicable first option for a company at this stage?
A) File a PMA immediately
B) Petition CDRH to downclassify the device
C) Resubmit a 510(k) with new data to demonstrate the device is
at least as safe and effective as the predicate.
D) Submit this product for approval in Europe - ANSWER C
9. The Medical Device User Fee and Modernization Act of 2002 enacted all
the following except:
A) User fees for premarket reviews
B) Office of Combination Products
C) Prescription Drug User Fee Act (PDUFA) renewal for five
additional years - ANSWER C
10.What is a major difference between an HDE and a PMA application?
A) Application form and content
B) Labeling requirements
C) Supplemental applications
D) Effectiveness requirements - ANSWER D
11.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
