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DEVICE RAC EXAM QUESTIONS AND
CORRECT ANSWERS
1. If your firm commercially distributes a Class III device that is
subject to PMA requirements without an approved Pre-market
Approval Application, what is the statutory violation?
A) Adulteration
B) Improper Use
C) Misbranding
D) Idiocy - correct answer - A
2. Pre-market Notification Requirements would apply to a device
that is:
A) Substantially equivalent to a pre-amendment device
B) Intended solely for use by a specific physician
C) Not equivalent to currently marketed devices
D) Intended for veterinary use - correct answer - A
3. 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
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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. - correct answer - C
4. 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 - correct answer - B
5. Which of the following conditions may be expected to lead to a
field recall action?
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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 - correct answer - B
6. 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 - correct answer -
C
7. 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 - correct answer - C
DEVICE RAC EXAM QUESTIONS AND
CORRECT ANSWERS
1. If your firm commercially distributes a Class III device that is
subject to PMA requirements without an approved Pre-market
Approval Application, what is the statutory violation?
A) Adulteration
B) Improper Use
C) Misbranding
D) Idiocy - correct answer - A
2. Pre-market Notification Requirements would apply to a device
that is:
A) Substantially equivalent to a pre-amendment device
B) Intended solely for use by a specific physician
C) Not equivalent to currently marketed devices
D) Intended for veterinary use - correct answer - A
3. 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
, Page | 2
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. - correct answer - C
4. 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 - correct answer - B
5. Which of the following conditions may be expected to lead to a
field recall action?
, Page | 3
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 - correct answer - B
6. 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 - correct answer -
C
7. 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 - correct answer - C
