Module 8 Investigational Device Exemptions (IDE)

Question 1

Devices are classified as
__
__
__

Answer 1

Class I
Class II
Class III

Question 2

A ___ is an instrument, apparatus, implement, machine, contrivance, or implant intended for use in the diagnosis of disease or conditions or in the cure, mitigation, treatment, or prevention of disease in man or other animals

Answer 2

Medical Device

Question 3

What is an example of a Class I device

Answer 3

Latex examination gloves

Question 4

Pacemakers, implanted weight loss devices and cochlear implants which class devices

Answer 4

Class III

Question 5

General controls for all classes of devices include (3)

Answer 5

1. register establishments and list medical devices with the FDA
2. manufacture in accordance with good manufacturing practices
3. label devices according to regulations

Question 6

Who makes the initial significant risk (SR) or non-significant risk (NSR) determination for a study

Answer 6

SPONSOR

Question 7

T/F
Significant risk devices studies must have an IDE approved by the FDA along with IRB approval. Once you have that approval you are exempt from additional FDA regulations.

Answer 7

FALSE

FDA has oversight for clinical investigations of any products they regulate

Question 8

Which of these would NOT be considered a significant risk device?

Pacemaker
tongue depressor
cerebral stent
cochlear implant

Answer 8

Tongue depressor

Question 9

T/F
If you have no plans for marketing an investigational device, you do not need an IDE

Answer 9

FALSE

A significant risk device study must have an approved IDE from the FDA.

Question 10

T/F
All investigational devices are required to have a label that contains the statement:

CAUTION Investigational Device. Limited by Federal (or United States) law to investigational use.

Answer 10

TRUE

Question 11

A predicate device is required for a ___

Answer 11

510(k)

Question 12

Which devices typically require premarket approval (PMA)

Answer 12

Class III devices

Question 13

A medical device intended for the treatment or diagnosis of a disease that affects fewer than 8000 individuals in the US each year is ___

Answer 13

HUD

Question 14

Which expanded access pathway allows for the use of an unapproved device without prior approval from the FDA

Answer 14

Emergency Use

Question 15

____ permits a device that is not approved for marketing to be shipped lawfully for the purpose of conducting investigations.

Answer 15

IDE

Question 16

What must the sponsor demonstrate in the IDE application (3)

Answer 16

1. There is reason to believe risks are outweighed by the benefits
2. Scientifically sound
3. reason to believe the device will be effective

Question 17

T/F
The sponsor identifies the non-significant risk device, which the IRB must approve, but the FDA has the final decision.

Answer 17

TRUE.