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 (

    • 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