21 CFR 812– Investigational Device Exemption​

Question 1

Transitional device

Answer 1

A device that FDA considered to be a new drug before May 28, 1976

Question 2

CBER

Answer 2

Center for Biologics Evaluation and Research

Question 3

CDER

Answer 3

Center for Drug Evaluation and Research

Question 4

21 CFR 812

Answer 4

Investigational Device Exemption​

Question 5

CI

Answer 5

(Clinical Investigation)

Question 6

Sponsor shall obtain financial disclosure and any relevant changes how often?

Answer 6

During clinical Investigation and for 1 year after Trial completion

Question 7

If sponsor determines that UADE presents unreasonable risk, sponsor shall terminate all CIs or parts of CI presenting that risk no later than

Answer 7

5 working days after determination, and not later than 15 working days after sponsor first received notice of the effect ​

Question 8

IRB Records shall be maintained with Part?

Answer 8

Part 56

Question 9

In 21 CFR Part 812, to what does “Act” refer?

Answer 9

Federal Food, Drug, and Cosmetic Act

Question 10

In 21 CFR Part 812, to what does “Implant” refer?

Answer 10

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

Question 11

In 21 CFR Part 812, to what does “Termination” refer?

Answer 11

discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion

Question 12

In 21 CFR Part 812, an investigation refers to research involving how many subjects to determine the safety or effectiveness of a device?

Answer 12

one or more

Question 13

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.

Answer 13

90 days

Question 14

Custom device means a device that:

Answer 14

-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

Question 15

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.

Answer 15

true

Question 16

_________ means an individual who actually conducts a clinical investigation

Answer 16

investigator

Question 17

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​

Answer 17

d) both a and c

Question 18

A person exporting an investigational device subject to 21 CFR Part 812 shall obtain FDA’s prior approval.

Answer 18

true

Question 19

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

Answer 19

b) significant risk device

Question 20

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

Answer 20

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

Question 21

According to 21 CFR Part 812, a monitor may be:​
​
a) an employee of the sponsor​
b) employee of or consultant to a CRO​
c) an employee of the investigator​
d) a consultant to the sponsor​
e) a, b, and d

Answer 21

e) a, b, and d

Question 22

Copies of all forms and informational materials to be provided to subjects to obtain informed consent must be included within the contents of the IDE application.​
​
true​
false

Answer 22

true​

Question 23

Report of prior investigations shall include which of the following information (mark all that apply):​
​
a) prior clinical, animal and laboratory testing of the device​
b) IRB information​
c) summary of all other unpublished information​
d) bibliography of all publications​
e) description of the device

Answer 23

a) prior clinical, animal and laboratory testing of the device​
​
c) summary of all other unpublished information​
d) bibliography of all publications

Question 24

Labeling of investigational devices shall include which of the following information (mark all that apply):​
​
a) description of all relevant contradictions, hazards, adverse effects, interfering substances or devices, warnings, and precautions​
b) name and place of business of the manufacturer, packer or distributor​
c) device is safe or effective for the investigational use​
d) quantity of contents​
e) “Caution-investigational device. Limited by Federal law to investigational use.”

Answer 24

a) description of all relevant contradictions, hazards, adverse effects, interfering substances or devices, warnings, and precautions​

​
b) name and place of business of the manufacturer, packer or distributor​
​
d) quantity of contents​

​
e) “Caution-investigational device. Limited by Federal law to investigational use.”