The US Food and Drug Administration (FDA) has granted more than $3.5m to various pediatric device consortia to encourage the development and availability of medical devices for children.
This grants program is administered by the FDA’s Orphan Product Development (OPPD) and is aimed at encompassing devices used in all pediatric diseases, not just rare diseases.
OPPD director Dr Gayatri R Rao noted these consortia are part of FDA’s commitment to medical product innovation in areas of unmet medical need and will support pediatric medical device progression through all stages of development — concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization.
"At each stage, the consortia will assess and provide meaningful feedback about the scientific and medical merit of proposed pediatric device projects," Dr Rao added.
The seven grant receivers will encourage innovation and connect qualified individuals with good pediatric device ideas to potential manufacturers, mentor and manage pediatric device projects through their development, including prototype design and marketing, connect innovators and physicians to existing federal and non-federal resources, and assess the scientific and medical merit of proposed pediatric projects and provide assistance and advice on business development, training, prototype development and post-marketing needs.
Every grant recipient will coordinate among the FDA, device companies, and the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development to facilitate research and any necessary applications for device approval or clearance.
The consortia and the FDA will work collaboratively to help innovators effectively navigate existing laws, regulations, and agency guidance to protect the health and safety of children.