Points of Clarity - Regulatory Compliance

  • The purpose of Nu-Life clinical programs or initiatives are to demonstrate that Nu-V3 and the Nu-V3 program comprehensive, safe, effective, simple to apply and easy to use.

  • Nu-V3 initiatives and clinical programs are Institutional Review Board (IRB) approved clinical trials and abide by all regulatory requirements and oversight by IRB, clinical principal investigators and our clinical team.

  • Although the Nu-V3 clinical programs are performed under strict regulatory standards, the clinical background and data for necessary for FDA clearance has already been documented and finalized.  

Golden Steel Plate
Clearance vs Approval

The Nu-V3 clinical program design is . . .

Golden Steel Plate
Device Classification 

The objectives for the Nu-V3 initiatives and clinical programs are . . . 

Golden Steel Plate
Safety Testing Clarified

It's important to understand how the clinical programs relate to regulatory clearances.  While regulatory agencies often require clinical data to determine the safety and effectiveness of a product or technology, the Nu-V3 clinical programs are strictly designed to demonstrate how Nu-V3 works for those who are considering treatment or recommending treatment.  For Nu-Life's FDA clearance submittal, all clinical data has already been collected and finalized.

Golden Steel Plate
IRB Trial Guidelines 

The Institutional Review Board (IRB) that Nu-Life has engaged to approve Nu-V3 for clinical trial is licensed by FDA for the purpose of assuring patient safety and adherence to regulatory standards.  Nu-Life has a very specific IRB strategy which is designed to coincide with Nu-V3's indications for use and patient populations so the greatest number of people may be treated under our foundational regulatory approvals.