DEVICE RAC EXAM 2025 QUESTIONS AND
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 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?
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
8. 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 - correct answer - D
9. The manufacturer of an approved prostate-specific antigen (PSA) test
developed a new automated analyzer to perform the total PSA testing.
There was no change to the test's indications for use or technology and
no new clinical data were required. Only analytical testing was
performed to demonstrate that the new analyzer did not alter the
performance of the assay. What kind of PMA supplement to the
approved PMA will be required for this change?
A) Special PMA Supplements Changes Being Affected
B) 30 day Notice
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 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?
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
8. 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 - correct answer - D
9. The manufacturer of an approved prostate-specific antigen (PSA) test
developed a new automated analyzer to perform the total PSA testing.
There was no change to the test's indications for use or technology and
no new clinical data were required. Only analytical testing was
performed to demonstrate that the new analyzer did not alter the
performance of the assay. What kind of PMA supplement to the
approved PMA will be required for this change?
A) Special PMA Supplements Changes Being Affected
B) 30 day Notice
