SOCRA ACTUAL 2026 TEST PAPER QUESTIONS AND
SOLUTIONS RATED A+
✔✔1) Are usually those that support or sustain human life
2) are of substantial importance in preventing the impairment of human health
3)Present a potential, unreasonable risk of illness or injury - ✔✔Class III Devices
Descriptions
✔✔Replacement heart valve
silicone-gel filled breast implants
implanted cerebella stimulators
implantable pacemakeres - ✔✔Examples of Class III Drugs
✔✔Powered wheel chairs
infusion pumps
surgical drapes - ✔✔Examples of Class II devices
✔✔Determined by the nature of the harm that may result to the subject in the study -
✔✔How is risk determined in device studies?
✔✔1) In an Implant
2)is used in supporting or sustaining life
3)is of substantial importance in diagnosing, curing, mitigating or treating disease or
other prevents impairment of human health
4)otherwise presents a potential for serious risk to the health, safety, or welfare of a
subject - ✔✔A Significant Risk (SR) Device Study is defined as:
✔✔Does not meet the criteria for significant risk - ✔✔How do you define a non-
significant risk device study?
✔✔The sponsor, the IRB evaluates the determination - ✔✔Who makes the initial
determination of SR or NSR?
✔✔The probability and magnitude of harm or discomfort anticipated in the research are
not greater in and of themselves than those ordinarily encountered in daily life or during
the performance of routine physical or psychological exams and tests - ✔✔IRB
definition of Minimal Risk
✔✔Significant Risk Trials - ✔✔What type of device studies are subject to all IDE
regulations (21 CFR Part 812)
✔✔Non-significant risk trials - ✔✔What type of device studies are subject to abbreviated
IDE regulations? (21 CFR Part 812.2b)
, ✔✔Pilot Study
Pivotal Study - ✔✔Types of Device Trials
✔✔the shipment of a device for the purpose of conducting investigations of the device
without complying without FDA requirements that would apply to devices in commercial
distribution - ✔✔What does an Investigational Device Exemption (IDE) permit?
✔✔1)Legally marketable device in accordance with its labeling
2)diagnostic device complying with labeling requirements, testing is non-invasive
3)Does not require invasive sampling procedure
4)Does not introduce energy into subject
5) It is not used as a diagnostic procedure without confirmation by a medically
established diagnostic product - ✔✔Devices can be granted IDE if:
✔✔1) Any serious adverse effect on health or safety or any life-threatening problem or
death caused by, or associated with a device
2)if that effect, problem, or death was not previously identified in nature, severity, or
degree of incidence in the investigational plan or application
2) any other unanticipated serious problem associated with a device that relates to the
rights, safety, or welfare of subjects - ✔✔Definition of Unanticipated adverse device
effect
✔✔Unanticipated adverse device effect (UADE) - ✔✔What is the SAE counterpart in
device trials?
✔✔Investigational agreement - ✔✔What is used in device studies instead of a 1572?
✔✔5 Working Days, IRB and sponsor - ✔✔What time frame and to whom do sites have
to report deviations from investigational plan in order to protect life or well being of
patients on device trials?
✔✔10 Working Days, Sponsor and reviewing IRB - ✔✔What timeframe and to whom do
investigators have to report UADEs?
✔✔5 Working Days (Sponsor and IRB) - ✔✔Notification time requirement for
emergency use of investigational device
✔✔Sponsor - ✔✔Who is responsible fore maintaining an effective IND or IDE?
✔✔Sponsor - ✔✔Who is responsible for ensuring all investigators are conducting
studies according to the general investigational plan and protocols in the IND?
SOLUTIONS RATED A+
✔✔1) Are usually those that support or sustain human life
2) are of substantial importance in preventing the impairment of human health
3)Present a potential, unreasonable risk of illness or injury - ✔✔Class III Devices
Descriptions
✔✔Replacement heart valve
silicone-gel filled breast implants
implanted cerebella stimulators
implantable pacemakeres - ✔✔Examples of Class III Drugs
✔✔Powered wheel chairs
infusion pumps
surgical drapes - ✔✔Examples of Class II devices
✔✔Determined by the nature of the harm that may result to the subject in the study -
✔✔How is risk determined in device studies?
✔✔1) In an Implant
2)is used in supporting or sustaining life
3)is of substantial importance in diagnosing, curing, mitigating or treating disease or
other prevents impairment of human health
4)otherwise presents a potential for serious risk to the health, safety, or welfare of a
subject - ✔✔A Significant Risk (SR) Device Study is defined as:
✔✔Does not meet the criteria for significant risk - ✔✔How do you define a non-
significant risk device study?
✔✔The sponsor, the IRB evaluates the determination - ✔✔Who makes the initial
determination of SR or NSR?
✔✔The probability and magnitude of harm or discomfort anticipated in the research are
not greater in and of themselves than those ordinarily encountered in daily life or during
the performance of routine physical or psychological exams and tests - ✔✔IRB
definition of Minimal Risk
✔✔Significant Risk Trials - ✔✔What type of device studies are subject to all IDE
regulations (21 CFR Part 812)
✔✔Non-significant risk trials - ✔✔What type of device studies are subject to abbreviated
IDE regulations? (21 CFR Part 812.2b)
, ✔✔Pilot Study
Pivotal Study - ✔✔Types of Device Trials
✔✔the shipment of a device for the purpose of conducting investigations of the device
without complying without FDA requirements that would apply to devices in commercial
distribution - ✔✔What does an Investigational Device Exemption (IDE) permit?
✔✔1)Legally marketable device in accordance with its labeling
2)diagnostic device complying with labeling requirements, testing is non-invasive
3)Does not require invasive sampling procedure
4)Does not introduce energy into subject
5) It is not used as a diagnostic procedure without confirmation by a medically
established diagnostic product - ✔✔Devices can be granted IDE if:
✔✔1) Any serious adverse effect on health or safety or any life-threatening problem or
death caused by, or associated with a device
2)if that effect, problem, or death was not previously identified in nature, severity, or
degree of incidence in the investigational plan or application
2) any other unanticipated serious problem associated with a device that relates to the
rights, safety, or welfare of subjects - ✔✔Definition of Unanticipated adverse device
effect
✔✔Unanticipated adverse device effect (UADE) - ✔✔What is the SAE counterpart in
device trials?
✔✔Investigational agreement - ✔✔What is used in device studies instead of a 1572?
✔✔5 Working Days, IRB and sponsor - ✔✔What time frame and to whom do sites have
to report deviations from investigational plan in order to protect life or well being of
patients on device trials?
✔✔10 Working Days, Sponsor and reviewing IRB - ✔✔What timeframe and to whom do
investigators have to report UADEs?
✔✔5 Working Days (Sponsor and IRB) - ✔✔Notification time requirement for
emergency use of investigational device
✔✔Sponsor - ✔✔Who is responsible fore maintaining an effective IND or IDE?
✔✔Sponsor - ✔✔Who is responsible for ensuring all investigators are conducting
studies according to the general investigational plan and protocols in the IND?
