RESOURCES
Useful Links
There are several resources out there to support pediatric medical device innovators. You can find links to many of them here. Is there something missing? send us an email and let us know.
PMD Launchpad (https://pmdlaunchpad.org/)
The Pediatric Medical Device Launchpad, created by the Pennsylvania Pediatric Device Consortium, is a platform to advance the conceptualization, development, marketing and manufacturing of pediatric medical devices.
More coming soon!
Terms and Acronyms
Medical device development has its own jargon; here are some commonly used terms:
AAP - The American Academy of Pediatrics
AdvaMed - The Advanced Medical Technology Association
BDD - Breakthrough Device Designation
CBER - The Center for Biologics Evaluation and Research
CDE - Custom Device Exemption
CDER - The Center for Drug Evaluation and Research
CDRH - The Center for Devices and Radiological Health
CMS - The Centers for Medicare and Medicaid Services
FDA - The United States Food and Drug Administration
HDE - Humanitarian Device Exemption
HHS - The United States Department of Health and Human Services
HUD - Humanitarian Use Device
IDE - Investigational Device Exemption
IMDRF - The International Medical Device Regulators Forum
IRB - Institutional Review Board
MDMA - The Medical Device Manufacturers Association
NEST - The National Evaluation System for Health Technology
NIH - The National Institutes of Health
OOPD - The Office of Orphan Product Development
PDC - The Pediatric Device Consortia program
PDP - Product Development Protocol
PMA - Premarket Approval
PMN - Premarket Notification
RWD - Real-World Data
RWE - Real-World Evidence
SaMD - Software as a Medical Device
SHIP-MD - System of Hospitals for Innovation in Pediatrics – Medical Devices