Early/Expanded Access

Question 1

What is the criteria, requirements and timeframe for emergency use

Answer 1

Criteria:
-Life-threatening or serious disease or condition
-No alternative
-no time to obtain FDA approval

Requirements:
-informed consent
-report to IRB within 5 days of use
-report to sponsor

Timeframe:
-before or after initiation of clinical trial

Question 2

What is the criteria, requirements and timeframe for compassionate use

Answer 2

Criteria
-serious disease or condition
-No alternative

Requirements
-Prior FDA approval of INK supplement

Timeframe:
-during clinical trial

Question 3

What is the criteria, requirements and timeframe for treatment use

Answer 3

Criteria
-life-threatening or serious disease
-no alternative
-controlled clinical trial
-sponsor pursuing marketing approval

Requirements:
-prior FDA approval of treatment IND

Timeframe:
-During clinical trial

Question 4

What is the criteria, requirements and timeframe for continued use

Answer 4

Criteria
-public health need
-preliminary evidence that the device will be effective and there are no significant safety concerns

Requirements:
-Prior FDA approval of IND supplement

Timeframe
-After completion of clinical trial