DEVICE RAC STUDY GUIDE 2026/2027 QUESTIONS AND
SOLUTIONS RATED A+
✔✔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 - ✔✔A) Substantially equivalent to a pre-amendment
device
✔✔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. - ✔✔C) Find something else to
worry about, contract sterilizers are not required to submit Device Listing forms for the
devices they manufacture.
✔✔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 - ✔✔B) Distributors
Distributors are not required to report to FDA
✔✔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 Federal Food, Drug & Cosmetic 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 - ✔✔B) Physical removal of device from point of use to other
location for repair, modification, adjustment, relabeling, destruction, or inspection
, ✔✔Which PMA supplements are NOT subject to user fee exemption?
A) Special PMA Supplements/CBE
B) PMA Manufacturing Site Change Supplements
C) Real Time Supplement
D) 30 Day Notices, 135 Day Supplements - ✔✔C) Real Time Supplement
✔✔An important distinction of a Humanitarian Use Device (HUD) according to the
Humanitarian Device Exemption (HDE) is that:
A) The HDE application must contain the same i,
B) An HDE application is not required to conta
C) An HDE application is not required to contain the results of scientifically valid clinical
investigations demonstrating effectiveness for its intended purpose.
D) An HDE application must be within 30 days a - ✔✔C) An HDE application is not
required to contain the results of scientifically valid clinical investigations demonstrating
effectiveness for its intended purpose.
Regulatory Reference: 21 CFR Part 814 (Subpart H)
✔✔A new Class II device with electrical components was subjected to extensive
standard testing such as the International Electrotechnical Commission (IEC) series
(recognized conformance standard). The tests were conducted by a third party. Which
route of submission is the most suitable for this device?
A Traditional 510k
B Special 510k
C Abbreviated 510k
D PMA - ✔✔C Abbreviated 510k
A manufacturer has the option to submit an Abbreviated 510(k) when FDA has
recognized relevant consensus standards that are applicable to the device. This
Abbreviated 510(k) will include a declaration of conformity to the recognized consensus
standards, and this declaration, in many cases, should eliminate the need to review
actual test data for those aspects of the device addressed by the standards, thus the
review will be more efficient. Regulatory Reference: FD&C Act Section 514 ; The New
510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in
Premarket Notifications—Final Guidance ; Guidance for Industry and FDA Staff:
Recognition and Use of Consensus Standards ; FDA Standards Database Search
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm) ; 21 CFR
Part 814.
✔✔In a device company, who has ultimate responsibility for data integrity and product
quality :
SOLUTIONS RATED A+
✔✔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 - ✔✔A) Substantially equivalent to a pre-amendment
device
✔✔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. - ✔✔C) Find something else to
worry about, contract sterilizers are not required to submit Device Listing forms for the
devices they manufacture.
✔✔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 - ✔✔B) Distributors
Distributors are not required to report to FDA
✔✔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 Federal Food, Drug & Cosmetic 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 - ✔✔B) Physical removal of device from point of use to other
location for repair, modification, adjustment, relabeling, destruction, or inspection
, ✔✔Which PMA supplements are NOT subject to user fee exemption?
A) Special PMA Supplements/CBE
B) PMA Manufacturing Site Change Supplements
C) Real Time Supplement
D) 30 Day Notices, 135 Day Supplements - ✔✔C) Real Time Supplement
✔✔An important distinction of a Humanitarian Use Device (HUD) according to the
Humanitarian Device Exemption (HDE) is that:
A) The HDE application must contain the same i,
B) An HDE application is not required to conta
C) An HDE application is not required to contain the results of scientifically valid clinical
investigations demonstrating effectiveness for its intended purpose.
D) An HDE application must be within 30 days a - ✔✔C) An HDE application is not
required to contain the results of scientifically valid clinical investigations demonstrating
effectiveness for its intended purpose.
Regulatory Reference: 21 CFR Part 814 (Subpart H)
✔✔A new Class II device with electrical components was subjected to extensive
standard testing such as the International Electrotechnical Commission (IEC) series
(recognized conformance standard). The tests were conducted by a third party. Which
route of submission is the most suitable for this device?
A Traditional 510k
B Special 510k
C Abbreviated 510k
D PMA - ✔✔C Abbreviated 510k
A manufacturer has the option to submit an Abbreviated 510(k) when FDA has
recognized relevant consensus standards that are applicable to the device. This
Abbreviated 510(k) will include a declaration of conformity to the recognized consensus
standards, and this declaration, in many cases, should eliminate the need to review
actual test data for those aspects of the device addressed by the standards, thus the
review will be more efficient. Regulatory Reference: FD&C Act Section 514 ; The New
510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in
Premarket Notifications—Final Guidance ; Guidance for Industry and FDA Staff:
Recognition and Use of Consensus Standards ; FDA Standards Database Search
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfstandards/search.cfm) ; 21 CFR
Part 814.
✔✔In a device company, who has ultimate responsibility for data integrity and product
quality :
