DEVICE RAC EXAM Questions and
Answers 2026/2027 |Already Graded
A+| Verified and Updated
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 - CORRECT ANSWER -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 - CORRECT ANSWER -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 - CORRECT ANSWER -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 - CORRECT ANSWER -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 - CORRECT ANSWER -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 - CORRECT ANSWER -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 - CORRECT
ANSWER -C
Answers 2026/2027 |Already Graded
A+| Verified and Updated
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 - CORRECT ANSWER -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 - CORRECT ANSWER -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 - CORRECT ANSWER -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 - CORRECT ANSWER -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 - CORRECT ANSWER -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 - CORRECT ANSWER -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 - CORRECT
ANSWER -C
