Guidance Specific to Pediatric Medical Devices

• Humanitarian Use Device (HUD) Designation - Guidance for Industry and Food and Drug Administration Staff
• Education and Media Resources for the Humanitarian Use Device (HUD) Designation Program
• Premarket Assessment of Pediatric Medical Devices - Guidance for Industry and Food and Drug Administration Staff
• Pediatric Medical Devices
• Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices

Other Useful Guidance and Information

• Division of Industry and Consumer Education (DICE) Contact
• Early Feasibility Study Guidance
• EFS CDRH Learn Modules
• Pre-Submission Guidance
• Design Controls Guidance
• IDE Submission Suggestions
• Electronic Submissions Guidance
• Expedited Access Pathway Program

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