21 CFR Part 812 Flashcards
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, of an investigation before completion
b) Federal Food, Drug, and Cosmetic Act
812. 3
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 28, 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
812. 3
In 21 CFR Part 812, to what does “Investigational Device” 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 3 days or more
c) device FDA considered to be a new drug or an antibiotic drug before May 28, 1976
a) device, including a transitional device, that is the object of an investigation
812. 3
In 21 CFR Part 812, to what does “Transitional Device” 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 3 days or more
c) device FDA considered to be a new drug or an antibiotic drug before May 28, 1976
c) device FDA considered to be a new drug or an antibiotic drug before May 28, 1976
812. 3
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
812. 3
In 21 CFR Part 812, an investigation refers to a clinical investigation or research involving how many subjects to determine the safety or effectiveness of a device?
a) one or more
b) 20-80
c) 100 or more
d) hundreds to thousands
a) one or more
In 21 CFR Part 812, to what does “Person” refer?
a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. Does not include any person other than an individual.
c) human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. Many be in normal health or may have a medical condition or disease.
d) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity
d) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity
812. 3
In 21 CFR Part 812, to what does “Monitor” refer?
a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. Does not include any person other than an individual.
c) one who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual
d) individual designated by a sponsor or contract research organization to oversee the progress of an investigation
e) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity
d) individual designated by a sponsor or contract research organization to oversee the progress of an investigation
812. 3
In 21 CFR Part 812, to what does “Institution” refer?
a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual designated by a sponsor or contract research organization to oversee the progress of an investigation
c) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity
a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
812. 3
In 21 CFR Part 812, to what does “Investigator” refer?
a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual designated by a sponsor or contract research organization to oversee the progress of an investigation
c) individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible team leader
d) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity
c) individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible team leader
812. 3
In 21 CFR Part 812, to what does “Subject” refer?
a) individual designated by a sponsor or contract research organization to oversee the progress of an investigation
b) human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. Many be in normal health or may have a medical condition or disease.
c) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity
b) human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. Many be in normal health or may have a medical condition or disease.
812. 3
In 21 CFR Part 812, to what does “Sponsor” refer?
a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. Does not include any person other than an individual.
c) one who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual
d) individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible team leader
c) one who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual
812. 3
In 21 CFR Part 812, to what does “Sponsor-Investigator” refer?
a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. Does not include any person other than an individual.
c) one who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual
d) individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible team leader
b) individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. Does not include any person other than an individual.
812. 3
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
812. 2(e)
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
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
false
true
812.7
_________ means an individual who actually conducts a clinical investigation.
a) monitor
b) sponsor
c) sponsor-investigator
d) investigator
d) investigator
812. 3
Implant means a 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 ____ days or more.
a) 5
b) 10
c) 30
d) 60
c) 30
812. 3
21 CFR Part 812:
a) encourages the discovery and development of useful devices intended for human use
b) applies to all clinical investigations of devices to determine safety and effectiveness
c) provides procedures for the conduct of clinical investigations of devices
d) all of the above
d) all of the above
812. 1
Which of the following is the definition of an unanticipated adverse device effect?
a) any serious adverse effect on health or safety or any live-threatening problem or death caused by, or associated with, a device if that effect, problem or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application
b) a device that is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject
c) any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects
d) both a and c
d) both a and c
812. 3
A person exporting an investigational device subject to 21 CFR Part 812 shall obtain FDA’s prior approval.
true
false
true
812.18
A person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the _________ of the clinical investigation.
a) investigator
b) monitor
c) sponsor
d) subject
c) sponsor
812. 3
A sponsor shall submit an application to the FDA if the sponsor intends to use a(n) _________ in an investigation, intends to conduct an investigation that involves an exception from informed consent under 21 CFR 812 part 50.24, or if FDA notifies the sponsor than an application is required for an investigation.
a) investigational device
b) significant risk device
c) implant
d) non-invasive device
b) significant risk device
812. 20(a)(1)
21 CFR Part 812 does not apply to a diagnostic device if the device (select all that apply):
a) does not require an invasive sampling procedure that presents significant risk
b) is invasive
c) introduces energy into a subject
d) is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure
a) does not require an invasive sampling procedure that presents significant risk
d) is not sued as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure
812. 2(c)(3)