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Adult Data To Support Pediatric Use? FDA Drafts Decision Tree To Assess Potential

FDA's device center issued draft guidance on leveraging existing adult – and some pediatric – clinical data for extrapolation to pediatric uses of devices.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The decision tree was circulated in a draft guidance

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