FDA Resources
FDA Programs and Resources
FDA’s Efforts to Optimize Medical Device Innovation for Pediatrics [PDF – 124 KB]
Pediatric Medical Device Homepage and Reports to Congress
Medical Device Development Tools (MDDT)
FDA Guidance Documents
Premarket Assessment of Pediatric Medical Devices
Providing Information about Pediatric Uses of Medical Devices
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Qualification of Medical Device Development Tools
FDA Public Meetings
Pediatric Medical Device Development – August 13-14, 2018, FDA White Oak Campus
SHIP-MD Pre-Consortium Meeting – February 9-11, 2021, Virtual
Pediatric Device Consortia Resources
Pediatric Device Consortia Grant Program
FDA PDC Useful Links for Pediatric Device Development
Software as a Medical Device and Digital Health
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Software as a Medical Device (SaMD): Clinical Evaluation
When a New 510k is Needed for a Change in Software in an Existing Device
Use of Off-The-Shelf Software in Medical Devices
General Principles of Software Validation; Final Guidance for Industry and FDA Staff
AdvaMed Cybersecurity Principles
SWPDC 