Miscellaneous Questions

Question 1

Class III Device

Answer 1

Devices wit the highest risk to patients

-subject to IDE application and pre market approval

Question 2

Class II device

Answer 2

Devices that pose a moderate risk

• subjected to special controls in addition to general controls
• must go through premarket control

Question 3

Class I Device

Answer 3

Devices that are those that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device

• lowest risk category
• exempt from IDE process and premarket review

Question 4

VAI

Answer 4

During FDA audit. Voluntary action indicated

-objectionable conditions or practices were found that do not meet the threshold of regulatory significance

Question 5

OAI

Answer 5

During FDA audit official action indicated
-when significant objectionable conditions or practices were found and regulatory action is warranted to address the lack of compliance with statuses or regulations

Question 6

NAI

Answer 6

During FDA audit no action indicated
-no objectionable condition or practices were found during inspection or significance of conditions found does not justify further actions

Question 7

Non significant device studies (NSR)

Answer 7

Follow abbreviated requirements

• do not need to have IDE application approved by FDA
• sponsors and IRB lbs do not have to report to FDA prior to study start

Question 8

Significant risk (SR) device studies

Answer 8

Follow all IDE regulations

-Have IDE application approved by FDA prior to study start

Question 9

3 types of medical device studies

Answer 9

• significant risk (SR)
• non-significant risk (NSR)
• exempt studies

Question 10

Investigator agreement

Answer 10

Used instead of FDA form 1572 for medical device studies

Question 11

Nuremberg code (1947)

Answer 11

The first set of principles outlining professional ethics for clinical research

Question 12

Belmont report (1979)

Answer 12

3 core principles

• respect for persons (informed consent)
• beneficence (risk/benefit analysis)
• Justice (appropriate selection of patients)

Question 13

Declaration of Helsinki (1964)

Answer 13

Developed by world medical associate with basis of Nuremberg code
-Laid out general principles that physicians should abide by when conducting research with human subjects

Question 14

Four components for short form consent process

Answer 14

1. Short form consent document
2. Oral presentation of the required elements of informed consent
3. IRB approved written summary of what is to be said
4. A witness must be present

Question 15

Language level for informed consent

Answer 15

6th to 8th grade

Question 16

Minimum number of IRB members needed

Answer 16

5

Question 17

Time required for IRB record retention

Answer 17

3 years after study completion

Question 18

Two common tools used for reducing bias

Answer 18

Blinding and randomization