DEVICE RAC STUDY EXAMS GUIDE CORRECT
QUESTIONS AND ANSWERS SURE A+
✔✔Under the Medical Device QSR, device design requirements MUST meet the needs
of the:
A. Manufacturer
B. Patient
C. User
D. Patient and user - ✔✔D
✔✔Under the IDE regulation, all of the following must be reported to the sponsor within
five working days EXCEPT:
A. A deviation from the investigational plan
B. Withdrawal of IRB approval
C. An unanticipated adverse device effect
D. Use of a device without informed consent - ✔✔C
✔✔Which of the following sections is required in a PMA?
A. Patent certification information
B. A copy of quality manual
C. An economic cost/benefit assessment
D. A discussion of benefit and risk considerations - ✔✔D
✔✔Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - ✔✔D
,✔✔A medical device is refused entry to the US. All of the following may be reasons for
refusal EXCEPT for the lack of:
A. Establishment registration by the foreign manufacturer
B. Medical device listing by the foreign manufacturer
C. Substantially equivalent letter from FDA
D. Establishment registration by the initial distributor - ✔✔A
✔✔Premarket Notification is required of manufacturers when introducing:
A. New label size
B. New Class II devices
C. A change in product name
D. Additional manufacturing sites - ✔✔B
✔✔All of the following are considered General Controls under the FD&C Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device - ✔✔B
✔✔Which of the following devices would be regulated by CBER?
A) Warming device
B) Blood pressure cuff
C) HIV diagnostic test kit
D) Capillary blood collection tube - ✔✔C
✔✔For a medical Device, what is NOT a responsibility of the US Agent for a Foreign
Establishment?
A) Report adverse events under the Medical Device Reporting regulation
B) Assisting FDA in communications with the foreign establishment,
C) Responding to questions concerning the foreign establishment's products that are
imported or offered for import into the United States, and
D) Assisting FDA in scheduling inspections of the foreign establishment. - ✔✔A
✔✔Which Congressional Act provided Statutory Authority to FDA to regulate medical
devices?
A) Safe Medical Devices Act of 1990
B) Medical Device User Fee and Modernization Act of 2002
C) Federal Food, Drug, Cosmetic Act
, D) Medical Device Amendments of 1976 - ✔✔D
✔✔Which of the following is NOT a key Medical Device submission which directly leads
to marketing permission from FDA?
A) 510(k), Pre-market Notification, Part 807
B) HDE, Humanitarian Device Exemption, Part 814
C) Premarket Approval (PMA), Part 814
D) IDE, Investigational Device Exemptions, Part 812 - ✔✔D
✔✔At completion of review of a 510(k), FDA may take the following actions except:
A) Declare device substantially equivalent
B) Declare device not substantially equivalent
C) State a 510(k) is not required to market the device
D) Approve the device for market - ✔✔D
✔✔From a pre-clinical viewpoint, which of the following constitute pre-clinical activities
in medical device development?
A) Animal use testing to validate the design of your device
B) Bench testing to verify that your design performs as designed
C) Biocompatibility/Toxicity testing
D) Functional/Safety/Performance testing
E) All of the above - ✔✔E
✔✔With respect to a Non-Significant Risk device clinical trial, which of the following is
NOT required before starting the trial?
A) Informed consent of trial participants
B) IRB approval of the trial
C) Financial disclosure by investigators
D) Submission of the trial protocol to FDA for approval - ✔✔D
✔✔The establishment, performance and auditing of a human-use clinical device trial
requires conformance with all of the following except:
A) 21 CFR 50 Protection of Human Subjects
B) 21 CFR 56 IRB
C) 21 CFR 807 Establishment Registration
D) 21 CFR 812 IDE Exemptions - ✔✔C
✔✔A key component of a new device for which a PMA is being prepared is
manufactured by a second company. Without revealing proprietary information to the
QUESTIONS AND ANSWERS SURE A+
✔✔Under the Medical Device QSR, device design requirements MUST meet the needs
of the:
A. Manufacturer
B. Patient
C. User
D. Patient and user - ✔✔D
✔✔Under the IDE regulation, all of the following must be reported to the sponsor within
five working days EXCEPT:
A. A deviation from the investigational plan
B. Withdrawal of IRB approval
C. An unanticipated adverse device effect
D. Use of a device without informed consent - ✔✔C
✔✔Which of the following sections is required in a PMA?
A. Patent certification information
B. A copy of quality manual
C. An economic cost/benefit assessment
D. A discussion of benefit and risk considerations - ✔✔D
✔✔Which of the following is exempt from GMP/QSR regulations?
A. Remanufacturers
B. Custom device manufacturers
C. Repackagers
D. Component manufacturers - ✔✔D
,✔✔A medical device is refused entry to the US. All of the following may be reasons for
refusal EXCEPT for the lack of:
A. Establishment registration by the foreign manufacturer
B. Medical device listing by the foreign manufacturer
C. Substantially equivalent letter from FDA
D. Establishment registration by the initial distributor - ✔✔A
✔✔Premarket Notification is required of manufacturers when introducing:
A. New label size
B. New Class II devices
C. A change in product name
D. Additional manufacturing sites - ✔✔B
✔✔All of the following are considered General Controls under the FD&C Act EXCEPT:
A. Establishment registration
B. Premarket approval application
C. Medical device reporting
D. Listing of the device - ✔✔B
✔✔Which of the following devices would be regulated by CBER?
A) Warming device
B) Blood pressure cuff
C) HIV diagnostic test kit
D) Capillary blood collection tube - ✔✔C
✔✔For a medical Device, what is NOT a responsibility of the US Agent for a Foreign
Establishment?
A) Report adverse events under the Medical Device Reporting regulation
B) Assisting FDA in communications with the foreign establishment,
C) Responding to questions concerning the foreign establishment's products that are
imported or offered for import into the United States, and
D) Assisting FDA in scheduling inspections of the foreign establishment. - ✔✔A
✔✔Which Congressional Act provided Statutory Authority to FDA to regulate medical
devices?
A) Safe Medical Devices Act of 1990
B) Medical Device User Fee and Modernization Act of 2002
C) Federal Food, Drug, Cosmetic Act
, D) Medical Device Amendments of 1976 - ✔✔D
✔✔Which of the following is NOT a key Medical Device submission which directly leads
to marketing permission from FDA?
A) 510(k), Pre-market Notification, Part 807
B) HDE, Humanitarian Device Exemption, Part 814
C) Premarket Approval (PMA), Part 814
D) IDE, Investigational Device Exemptions, Part 812 - ✔✔D
✔✔At completion of review of a 510(k), FDA may take the following actions except:
A) Declare device substantially equivalent
B) Declare device not substantially equivalent
C) State a 510(k) is not required to market the device
D) Approve the device for market - ✔✔D
✔✔From a pre-clinical viewpoint, which of the following constitute pre-clinical activities
in medical device development?
A) Animal use testing to validate the design of your device
B) Bench testing to verify that your design performs as designed
C) Biocompatibility/Toxicity testing
D) Functional/Safety/Performance testing
E) All of the above - ✔✔E
✔✔With respect to a Non-Significant Risk device clinical trial, which of the following is
NOT required before starting the trial?
A) Informed consent of trial participants
B) IRB approval of the trial
C) Financial disclosure by investigators
D) Submission of the trial protocol to FDA for approval - ✔✔D
✔✔The establishment, performance and auditing of a human-use clinical device trial
requires conformance with all of the following except:
A) 21 CFR 50 Protection of Human Subjects
B) 21 CFR 56 IRB
C) 21 CFR 807 Establishment Registration
D) 21 CFR 812 IDE Exemptions - ✔✔C
✔✔A key component of a new device for which a PMA is being prepared is
manufactured by a second company. Without revealing proprietary information to the
