DEVICE RAC MAIN EXAMINATION MANUAL 2026/2027
QUESTIONS AND SOLUTIONS RATED A+
✔✔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
finished product manufacturer, how can the component manufacturer make critical
information available to FDA for review?
A) Submit a Device Master File (MAF)
B) File its own PMA
C) Supply the applicable sections of the finished device manufacturer's PMA directly to
FDA
D) Include a certification in the finished device manufacturer's PMA that the proprietary
information meets FDA's requirements - ✔✔A
✔✔Under the official definition of a "device", all of the following are considered devices
except:
A) X-ray film
B) Sterilizers used for device manufacturing
C) Eyeglass lenses and frames
D) In vitro diagnostic kit - ✔✔B
✔✔510(k) Premarket Notifications for all of the following medical devices would be
reviewed by CDRH's Office of Device Evaluation except:
A) High Flux Hemodialyzer
B) Blood specimen collection device
C) Piston syringe
D) Cardiopulmonary bypass blood tubing - ✔✔B
, ✔✔The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to
the manufacturing of which of the following:
A) Finished devices, but not accessories
B) Finished devices and components of finished devices
C) Finished devices and accessories to finished devices
D) Finished devices, components, and accessories to finished devices - ✔✔C
✔✔The QSR for Class III devices applies to the following except:
A) Critical component manufacturers
B) Operations done by the manufacturer at facilities located in the United States
C) Research on investigational devices tested outside of the United States
D) Contract Sterilizers - ✔✔A
✔✔The QSR for medical devices (21CFR 820) requires all of the following except:
A) Management to make a commitment to quality
B) A Quality Plan that defines how quality will be met
C) Management must review the Quality System at least quarterly
D) A Quality representative must be identified and documented - ✔✔C
✔✔The QSR for medical devices regarding Design Controls require which of the
following:
A) Documentation of early research of the design
B) Design and development plans address how design inputs and requirements are
managed
C) A product design can be outsourced by a manufacturer so they do not have to
maintain the documentation
D) Design activities are only required for Class III Investigational devices - ✔✔B
✔✔Design Control "verification" requires which of the following:
A) The product design meets the users needs
B) The process produces a product that meets predetermined specifications
C) The product design meets specified requirements
D) The product design meets the intended use requirements - ✔✔C
✔✔According to the QSR, Design Inputs are best described by the following:
A) The Operator's Manual and instructions on how to use the device
B) The Instructions For Use (IFU) of the device
C) Marketing claims and features that are required for the device
D) The performance requirements that the product must meet - ✔✔D
QUESTIONS AND SOLUTIONS RATED A+
✔✔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
finished product manufacturer, how can the component manufacturer make critical
information available to FDA for review?
A) Submit a Device Master File (MAF)
B) File its own PMA
C) Supply the applicable sections of the finished device manufacturer's PMA directly to
FDA
D) Include a certification in the finished device manufacturer's PMA that the proprietary
information meets FDA's requirements - ✔✔A
✔✔Under the official definition of a "device", all of the following are considered devices
except:
A) X-ray film
B) Sterilizers used for device manufacturing
C) Eyeglass lenses and frames
D) In vitro diagnostic kit - ✔✔B
✔✔510(k) Premarket Notifications for all of the following medical devices would be
reviewed by CDRH's Office of Device Evaluation except:
A) High Flux Hemodialyzer
B) Blood specimen collection device
C) Piston syringe
D) Cardiopulmonary bypass blood tubing - ✔✔B
, ✔✔The Quality System Regulation (QSR) for medical devices (21CFR 820) pertains to
the manufacturing of which of the following:
A) Finished devices, but not accessories
B) Finished devices and components of finished devices
C) Finished devices and accessories to finished devices
D) Finished devices, components, and accessories to finished devices - ✔✔C
✔✔The QSR for Class III devices applies to the following except:
A) Critical component manufacturers
B) Operations done by the manufacturer at facilities located in the United States
C) Research on investigational devices tested outside of the United States
D) Contract Sterilizers - ✔✔A
✔✔The QSR for medical devices (21CFR 820) requires all of the following except:
A) Management to make a commitment to quality
B) A Quality Plan that defines how quality will be met
C) Management must review the Quality System at least quarterly
D) A Quality representative must be identified and documented - ✔✔C
✔✔The QSR for medical devices regarding Design Controls require which of the
following:
A) Documentation of early research of the design
B) Design and development plans address how design inputs and requirements are
managed
C) A product design can be outsourced by a manufacturer so they do not have to
maintain the documentation
D) Design activities are only required for Class III Investigational devices - ✔✔B
✔✔Design Control "verification" requires which of the following:
A) The product design meets the users needs
B) The process produces a product that meets predetermined specifications
C) The product design meets specified requirements
D) The product design meets the intended use requirements - ✔✔C
✔✔According to the QSR, Design Inputs are best described by the following:
A) The Operator's Manual and instructions on how to use the device
B) The Instructions For Use (IFU) of the device
C) Marketing claims and features that are required for the device
D) The performance requirements that the product must meet - ✔✔D
