The FDA will begin requiring device manufacturers to provide readily available information in certain premarket applications on pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure--even if the device is only intended for adults. If the manufacturer does not submit such information, the FDA may not approve the application until the required data are provided.
Very few devices are developed or assessed specifically for use in patients younger than 21 years, so this effort will provide a better understanding of what devices developed for adults should be assessed or modified for use in pediatric populations, according to an FDA announcement. And, as Mass Device points out, efforts to encourage devicemakers to develop pediatric devices are picking up--including those by Massachusetts-based Institute for Pediatric Innovation (IPI) and Cleveland-based PediaWorks.
In January, IPI announced the development of a new pediatric endotracheal tube for neonatal care and a vein transilluminator that will reduce the number of needle sticks required to locate a vein. The work is funded by a $200,000 contract from a medical device company.
- read the FDA's statement
- see Mass Device's coverage
- check out the IPI announcement