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DEVICE RAC EXAM BRAND NEW OFFICIAL
QUESTIONS WITH ANSWERS.
According to the QSR, Quality Audits must accomplish the
following:
A) Meet the same requirements of the original GMP
B) Evaluate if the Quality System is in compliance with the QSR
C) Determine the effectiveness of the Quality System
D) Focus on Design Controls and the CAPA system
E) B and C above
F) A and D above - correct answer -E
According to the QSR, personnel involved in the design,
manufacture, distribution, servicing, and reporting must:
A) Must hold a Master's degree or higher
B) At a minimum receive procedure training once per year in their
area of responsibility
C) Be able to recite the Quality Policy, if asked
D) Be made aware of defects which may occur if they do not
perform their job correctly - correct answer -D
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According to the QSR, Document Controls apply to:
A) Design History File (DHF)
B) Device Master Record (DMR)
C) Device History Record (DHR)
D) All of the above - correct answer -D
All of the following are considered General Controls under the
FD&C Act except:
A) Establishment Registration
B) Pre-market Approval Application
C) Quality System Regulation
D) Device Listing - correct answer -B
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
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B) Improper Use
C) Misbranding
D) Idiocy - correct answer -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 - correct answer -A
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.
DEVICE RAC EXAM BRAND NEW OFFICIAL
QUESTIONS WITH ANSWERS.
According to the QSR, Quality Audits must accomplish the
following:
A) Meet the same requirements of the original GMP
B) Evaluate if the Quality System is in compliance with the QSR
C) Determine the effectiveness of the Quality System
D) Focus on Design Controls and the CAPA system
E) B and C above
F) A and D above - correct answer -E
According to the QSR, personnel involved in the design,
manufacture, distribution, servicing, and reporting must:
A) Must hold a Master's degree or higher
B) At a minimum receive procedure training once per year in their
area of responsibility
C) Be able to recite the Quality Policy, if asked
D) Be made aware of defects which may occur if they do not
perform their job correctly - correct answer -D
, Page | 2
According to the QSR, Document Controls apply to:
A) Design History File (DHF)
B) Device Master Record (DMR)
C) Device History Record (DHR)
D) All of the above - correct answer -D
All of the following are considered General Controls under the
FD&C Act except:
A) Establishment Registration
B) Pre-market Approval Application
C) Quality System Regulation
D) Device Listing - correct answer -B
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
, Page | 3
B) Improper Use
C) Misbranding
D) Idiocy - correct answer -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 - correct answer -A
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.
