FDA regulations

• FDA IND regulations

FDA guidance and forms

• FDA website for investigators
• Guidance for industry - E6(R2) good clinical practice: Integrated addendum to ICH E6(R1)
• FDA IND forms
  • Form 1571
  • Form 1571 instructions
  • Form 1572
  • Form 1572 instructions
  • Form 3674
  • Form 3674 instructions
  • Form 3454
  • Form 3455
  • Checklist for IND application submissions

FDA expanded access guidance and forms

• Form FDA 3926
• Individual patient expanded access applications: Form FDA 3926 guidance for industry
• Charging for Investigational Drugs Under an IND — Questions and answers guidance for industry

FDA regulations

• FDA IDE regulations

FDA guidance and forms

• FDA device advice website
• FDA IDE website
• How to classify your device
• Guidance for industry - E6(R2) good clinical practice: Integrated addendum to ICH E6(R1)
• FDA IDE forms
  • Form 3674
  • Form 3674 instructions

IDE general information

• IDE flowchart
• Significant risk IDE sponsor and investigator responsibilities
• Non‐significant risk IDE sponsor and investigator responsibilities

IDE templates

• IDE investigator agreement for clinical investigation
• Documentation of NSR determination

IDE education

On-demand investigational device exemptions sponsor and investigator training modules are available through Talent@VCU.

How to access modules in Talent@VCU:

• Log in to Talent@VCU at go.vcu.edu/talentatvcu
• Search for the course name or expand the subject drop-down and check “Research”
• Request and launch

Kaltura videos:

• VCU video: Investigational medical devices
• VCU video: NSR medical devices