The Food & Drug Administration will require medical device manufacturers to include information on the pediatric population that might be served by devices they’re seeking approval for from the agency.
The requirement, which was part of the Food & Drug Administration Amendments Act passed in 2007, applies even to devices intended for use in adults. The new rule is aimed at improving the identification of devices that could be used to treat children and at enhancing the agency’s ability to track those devices and devices approved for use in pediatric patients.
Because the market for devices sized for children is much smaller than for adult-sized products, few wind up being commercialized. Non-profit efforts to encourage device makers to develop pediatric devices are gaining steam, however, including the Cambridge, Mass.-based Institute for Pediatric Innovation and Cleveland-based PediaWorks.
IPI COO Ross Trimby told MassDevice he sees nothing but upside in the new rules.
"Having existing companies recognize and quantify the pediatric uses of any of their devices during the approval process is going to be a nice awakening experience for them all, in terms of what the actual implications are in terms of selecting that device for pediatric use," Trimby told us. "Just having these companies that are bringing out a product that is certainly going to be used in pediatric care [anyway] actually look at that while they’re going through the regulatory process will help them make the decision that this is a market opportunity they should go after."
Asked if the new rules are any cause for worry that companies, having done their evaluations, might decide the pediatric market is not worth pursuing, Trimby said the regulations are "nothing but good news."
"We are in favor of getting products out there that can stand on their own economically. If a product is so singularly used that there are no economics it … in those cases we think we have to figure out another way," he said. "This is just another case of increased Washington recognition, of bringing attention to the lack of appropriate products being sold and marketed to pediatric applications, as opposed to having doctors and hospitals go out and find something that fits their needs. Getting Washington to recognize that this is an identified problem and helping bring about a solution is nothing but good news."
In January, IPI announced a joint program with hospitals in California and Ohio to develop a new pediatric endotracheal tube optimized for neonatal care and a vein transilluminator designed to reduce the number of needle sticks required to locate a vein. The institute, which will manage the development of the devices, said the work is being funded by a $200,000 contract with an un-named medical device company. The hospitals will provide end-user input on the design of the devices, which are expected to be ready for the marketplace by the fourth quarter.
Donald Lombardi, founder and CEO of the four-year-old nonprofit, is a former intellectual property chief at Boston’s Children’s Hospital. At the time Lombardi told us that the institute goes through a rigorous process to find products that are both clinically needed and commercially viable.
Under the FDA’s new requirement, manufacturers must provide "readily available" pediatric information with each pre-market approval application or supplement, humanitarian device exemption request or product development protocol. Those submissions must include a description of any pediatric sub-populations that suffer from the disease or condition the device is intended to treat and the number of affected pediatric patients. The federal watchdog said it might hold applications from companies that don’t provide the data until the information is submitted.