The Food and Drug Administration announced that they will begin implementing a requirement that device manufacturers will have to provide information on pediatric patients that suffer the condition disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use.

The requirement is intended for devices used in adults, the agency warned manufacturers, that if failed to comply with it, they will deny approval.

According to the FDA, very few devices are manufactured specifically for patients under 21 years old, however this effort will allow them to better asses pediatric needs.

Under the current Food and Drug Administration Amendments Act of 2007, this requirement was already requested but it also improve the agency´s capacity to monitor any approved device for pediatric population.