21 CFR 812– Investigational Device Exemption Flashcards
Transitional device
A device that FDA considered to be a new drug before May 28, 1976
CBER
Center for Biologics Evaluation and Research
CDER
Center for Drug Evaluation and Research
21 CFR 812
Investigational Device Exemption
CI
(Clinical Investigation)
Sponsor shall obtain financial disclosure and any relevant changes how often?
During clinical Investigation and for 1 year after Trial completion
If sponsor determines that UADE presents unreasonable risk, sponsor shall terminate all CIs or parts of CI presenting that risk no later than
5 working days after determination, and not later than 15 working days after sponsor first received notice of the effect
IRB Records shall be maintained with Part?
Part 56
In 21 CFR Part 812, to what does “Act” refer?
Federal Food, Drug, and Cosmetic Act
In 21 CFR Part 812, to what does “Implant” refer?
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?
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?
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.
90 days
Custom device means a device that:
-necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement,
-is not generally available to, or generally used by, other physicians,
-is not generally available in finished form for purchase or prescription,
-is not offered for commercial distribution through labeling or advertising
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
investigator
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
A person exporting an investigational device subject to 21 CFR Part 812 shall obtain FDA’s prior approval.
true
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
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 used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure
