Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables

Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations From Pediatric Innovator Roundtables

Objective: The purpose of this report is to provide insight from pediatric stakeholders with a shared desire to facilitate a revision of the current United States regulatory pathways for the development of pediatric healthcare devices. Methods: On August 5, 2020, a group of innovators, engineers, pr...

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Bibliographic Details
Main Authors: Terence Sanger, Anthony Chang, William Feaster, Sharief Taraman, Nadine Afari, Debra Beauregard, Brent Dethlefs, Tiffani Ghere, Mustafa Kabeer, George Tolomiczenko, Michael Billig, Jon Brophy, Kolaleh Eskandanian, Juan Espinoza, Sherry Farrugia, Michael Harrison, Christopher Horvat, Claudia Hoyen, Chester Koh, Allison Komiyama, Krista Nelson, Omkar Kulkarni, Robert Levy, Kevin Maher, Michael O'Donnell, Todd Ponsky, Frances Richmond, Jessica Richter, Shuvo Roy, Shreim Samir, Srinivasan Suresh, Charlette Stallworth, Usha Thekkedath, Kara Toman, James Wall, Leanne West, Dawn Wolff
Format: Article
Language:English
Published: IEEE 2021-01-01
Series:IEEE Journal of Translational Engineering in Health and Medicine
Subjects:
Device
FDA
guidelines
pediatric
regulatory
Online Access:https://ieeexplore.ieee.org/document/9465164/

Internet

https://ieeexplore.ieee.org/document/9465164/

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