Investigational Device Exemption (IDE) Flashcards
A sponsor who makes a cardiac pacemaker has secured a PMA for the device. The sponsor decides to make a minor modification to the pacemaker. The sponsor must:
a) Notify the FDA by letter of his decision
b) Make the modification if it is minor without notification
c) File for a 510K
d) File an IDE because it is significant risk device.
d) File an IDE because it is significant risk device.
A 510k premarket notification is submitted:
a) When the device is a Class I device only
b) Before the initiation of a clinical trail
c) When the device is intended for population of less than 4000
d) When the device to be marketed is substantially equivalent to the current approved device
d) When the device to be marketed is substantially equivalent to the current approved device
An IDE is required before a new device:
a) Can be evaluated in a clinical trial
b) Shipped across state lines
c) Both a and b
d) Neither a nor b
c) Both a and b
An MRI machine and a thermometer are examples of:
a) Class I devices
b) Class II devices
c) Class III devices
d) Class IV devices
b) Class II devices
An abbreviated IDE is:
a) A shorter IDE application to the FDA
b) A variation on a 510K application
c) An alternative to the FDA IDE application process
d) An IRB SR/NSR determination for a device
d) An IRB SR/NSR determination for a device
An HUD is a device:
a) Applicable to less than 4000 individuals
b) A device for which a clinical trial to prove effectiveness is not required
c) For which no comparable device exists on the market
d) All of the above
d) All of the above
a) Applicable to less than 4000 individuals
b) A device for which a clinical trial to prove effectiveness is not required
c) For which no comparable device exists on the market
A small hospital without an IRB has an urgent need to use a HUD. The hospital:
a) May file for an HDE
b) Use the device anyway
c) Inform the FDA of its intent to use the device
d) May not use the device as it does not have an IRB
d) May not use the device as it does not have an IRB
A regulatory path to market for a device may include:
a) An IDE
b) A PMA
c) A 510K application
d) An HDE
e) All of the above.
e) All of the above.
a) An IDE
b) A PMA
c) A 510K application
d) An HDE
The sequence of regulatory events for approval of marketing for a device is:
a) Preclinical studies- IDE-PMA
b) Preclinical studies- PMA-IDE
c) 510K-IDE-PMA
d) HDE-510K-PMA
a) Preclinical studies- IDE-PMA
A non-significant risk determination for a study planned by an investigator is:
a) Made by the sponsor
b) Made by the FDA
c) Made by OHRP
d) Made by the IRB
d) Made by the IRB
A significant risk device is:
a) Implantable
b) Poses a serious risk to health
c) Mitigates a serious risk to subject
d) Essential for diagnosis, treatment or cure
e) All of the above.
e) All of the above.
a) Implantable
b) Poses a serious risk to health
c) Mitigates a serious risk to subject
d) Essential for diagnosis, treatment or cure
An IDE exemption may be granted if:
a) The device has a 510K
b) The study uses an approved device on label
c) The device is a non-significant risk device
d) All of the above.
d) All of the above.
a) The device has a 510K
b) The study uses an approved device on label
c) The device is a non-significant risk device
An adverse event in a device study is reported to the FDA if it is:
a) Serious
b) Serious and unanticipated
c) Serious and unanticipated and possibly related
d) Serious and unanticipated and probably related.
a) Serious
An investigator participating in a device study must complete:
a) A 1572
b) A 1571
c) An investigator agreement
d) A form from Appendix M
c) An investigator agreement
The sequence of clinical trials for a device study:
a) Phase 1-2-3-4
b) Phase 1-2-3
c) A single clinical trial
d) A feasibility study followed by a pivotal study.
d) A feasibility study followed by a pivotal study.
Sample populations in device studies:
a) Tend to be derived from a single site
b) Must have at least 100 subjects
c) Must be at least 1% of the target disease population
d) Tend to be much smaller than in drug studies.
d) Tend to be much smaller than in drug studies.
Before an HUD is used in a hospital the application must:
a) Have review and approval from the IRB
b) Have institutional approval
c) Have only the sponsor’s approval
d) Have an approved HDE from the FDA only
a) Have review and approval from the IRB
An HUD requires all of the following except:
a) Collecting research data for effectiveness
b) Safety reports to the FDA
c) Annual report to the FDA
d) Informed consent only if the IRB requires one
a) Collecting research data for effectiveness
