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.