Document Type

Article

Publication Date

6-25-2021

Identifier

DOI: 10.1109/JTEHM.2021.3092559; PMCID: PMC8313015

Abstract

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, professors and clinicians met to discuss challenges and opportunities for the development of new medical devices for pediatric health and the importance of creating a regulatory environment that encourages and accelerates the research and development of such devices. On January 6, 2021, this group joined regulatory experts at a follow-up meeting.

RESULTS: One of the primary issues identified was the need to present decision-makers with opportunities that change the return-on-investment balance between adult and pediatric devices to promote investment in pediatric devices.

DISCUSSION/CONCLUSION: Several proposed strategies were discussed, and these strategies can be divided into two broad categories: 1. Removal of real and perceived barriers to pediatric device innovation; 2. Increasing incentives for pediatric device innovation.

Journal Title

IEEE J Transl Eng Health Med

Volume

9

First Page

4800105

Last Page

4800105

Keywords

Device; FDA; guidelines; pediatric; regulatory

Comments

This work is licensed under a Creative Commons Attribution 4.0 License. For more information, see https://creativecommons.org/licenses/by/4.0/ 4.

Publisher's Link: https://doi.org/10.1109/jtehm.2021.3092559

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