PDC Useful Links
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