Think your PMA is complete? Better make sure it includes information about how your company's device affects kids. According to a release on FDA's Web site, the agency is implementing a requirement that manufacturers provide information in certain PMAs about pediatric patients who suffer from the condition that the device will treat–even if the device is intended for adult use.

The agency says that there is a shortage of devices developed for patients under the age of 21. By collecting such information in PMAs, FDA can better assess which adult devices should be evaluated for use in youth.

This requirement was mandated by the Food and Drug Administration Act of 2007. FDA says it may not approve a PMA if a manufacturer fails to submit the pediatric information.