In addition, the activity level and ability to manage some implantable or long-term devices may vary greatly among children.
A panel of six experts with experience in medicine, business, and device development reviewed 16 applications for the grants, which will be administered by the FDA’s Office of Orphan Products Development.
The recipients and grant amounts include:
James Geiger, M.D., and the Michigan Pediatric Device Consortium, $1 million
Pedro DelNido, M.D., and the Pediatric Cardiovascular Device Consortium, $500,000
Michael Harrison, M.D., and the University of California at San Francisco Pediatric Device Consortium, $500,000.
“Congress provided the FDA with this funding so that we could help connect innovators and their ideas with experienced professionals who assist them through development” said Timothy Cote, director of the FDA’s Office of Orphan Product Development. “These grants will strengthen public health by spurring the development of medical devices that safely and effectively meet the special and unique needs of our children.”