RECENT ADVANCEMENT IN PEDIATRIC MEDICAL DEVICE DEVELOPMENT AND APPROVAL OF USFDA

Abstract

The challenge in pediatric medical device development known as FDA barriers can be elaborated by the impacts of the characteristics and regulatory, ethical, and financial barriers in view that physiological and developmental aspects of children and adults vary. Although babies and children are some of the most frequently monitored patients, there are not many devices on the market, which are child-specific in terms of design, testing, and approval. This review discusses recent progress in the area, e.g., 3D printing of individualized devices; the existence of pediatric-specific biomarkers that allow early diagnosis of the diseases; innovations of critical care and near-infrared spectroscopy, and the development of smart ventilators. It also outlines the major regulatory pathways that have been used by the U.S. Food and drug administration (FDA) to approve pediatric devices, and such include the 510(k) premarket notification, Premarket approval (PMA), De novo designation, and humanitarian device exemption (HDE). These actions are part of a continuous progress towards the reduction of the innovation gap in pediatric care and more effective medical devices used with children.