FDA's device center issued draft guidance on leveraging existing adult – and some pediatric – clinical data for extrapolation to pediatric uses of devices. It provides a decision tree for device sponsors to help determine if available data is suitable to demonstrate safety and effectiveness in a younger population.
FDA has come up with a decision tree that sponsors can use to see if existing clinical data in adults is robust enough and generally suitable to extrapolate to support safety and effectiveness of use of a device in children.
The decision tree was circulated in a draft guidance