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CCRP SOCRA Exam - 21 CFR Part 812 test questions and answers 2024
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CCRP SOCRA Exam - 21 CFR Part 812 test questions and answers 2024
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CCRP SOCRA Exam - 21 CFRPart 812 test questions and
answers 2024
What does Title 21 CFR Part 812 cover?
Investigational Device Exemptions
In 21 CFR Part 812, to what does "Act" refer?
a) clinical investigation or research involving one or more subjects
b) Federal Food, Drug, and Cosmetic Act
c) discontinuance, by sponsor or by withdrawal of IRB or FDA approval
b) Federal Food, Drug, and Cosmetic Act
In 21 CFR Part 812, to what does "Implant" refer?
a) device, including a transitional device, that is the object of an
investigation
b) device that is placed into a surgically or naturally formed cavity of the
human body if it is intended to remain there for a period of 30 days or
more
c) device FDA considered to be a new drug or an antibiotic drug before
May 1976
b) device that is placed into a surgically or naturally formed cavity of the
human body if it is intended to remain there for a period of 30 days or
more
In 21 CFR Part 812, to what does "Termination" refer?
a) clinical investigation or research involving one or more subjects
b) serious adverse effect resulting in death or other permanently altered
physical or mental state
c) discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of
an investigation before completion
c) discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of
an investigation before completion
In 21 CFR Part 812, an investigation refers to research involving how many
subjects to determine the safety or effectiveness of a device?
, a) one or more
b) 5-25
c) 25-100
d) hundreds to thousands
a) one or more
A sponsor that, on July 16, 1980, has an effective IND application for an
investigation of a device shall continue to comply with the requirements of
21 CFR Part 312 until ____ days after that date.
a) 30
b) 60
c) 90
d) 120
C) 90
Custom device means a device that:
a) necessarily deviates from devices generally available or from an
applicable performance standard or premarket approval requirement
b) is not generally available to, or generally used by, other physicians
c) is not generally available in finished form for purchase or prescription
d) is not offered for commercial distribution through labeling or
advertising
e) all of the above
e) all of the above
812.3
True or False:
A sponsor, investigator, or any person acting for or on behalf of a sponsor
or investigator shall not promote or test market an investigational device
until after FDA has approved the device for commercial distribution.
True
_________ means an individual who actually conducts a clinical
investigation.
a) monitor
b) sponsor
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