FDA Guidance

• 21 CFR 50 - Regulations enforced by the Food and Drug Administration (FDA) - Protection of Human Subjects
• FDA Guidance - Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators
• Investigational Device Exemptions (IDE)
• Investigational Device Exemptions (IDE) for Custom and Diagnostic Devices
• Investigational New Drug (IND) Applications
• Investigational New Drug (IND) Applications for Bioavailability or Bioequivalence Studies
• UM Electronic Signature Certification
• Self-Assessment of eResearch Compliance with 21 CFR Part 11, Electronic Record; Electronic Signatures