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RAC DEVICES EXAM, PRACTICE EXAM AND STUDY GUIDE NEWEST 2024 ACTUAL COMPLETE 500 QUESTIONS AND 100% CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY GRADED A+$18.99
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RAC DEVICES EXAM, PRACTICE EXAM AND STUDY GUIDE NEWEST 2024 ACTUAL COMPLETE 500 QUESTIONS AND 100% CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY GRADED A+
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Course
RAC DEVICES
Institution
RAC DEVICES
RAC DEVICES EXAM, PRACTICE EXAM AND STUDY GUIDE NEWEST 2024 ACTUAL COMPLETE 500 QUESTIONS AND 100% CORRECT DETAILED ANSWERS (VERIFIED ANSWERS) |ALREADY GRADED A+
RAC DEVICES EXAM, PRACTICE
EXAM AND STUDY GUIDE NEWEST
2024 ACTUAL COMPLETE 500
QUESTIONS AND 100% CORRECT
DETAILED ANSWERS (VERIFIED
ANSWERS) |ALREADY GRADED A+
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 - ....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 - ....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 - ....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 - ....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 -
....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 - ....ANSWER...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 - ....ANSWER...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
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