Adult Data To Support Pediatric Use? FDA Drafts Decision Tree To Assess Potential
This article was originally published in The Gray Sheet
FDA's device center issued draft guidance on leveraging existing adult – and some pediatric – clinical data for extrapolation to pediatric uses of devices.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.
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Industry has asked FDA to expand the scope of its guidance on extrapolating adult trial data to pediatric submissions to include 510(k)s. In a final guidance, FDA declined to do so, but it did expand the scope of the guidelines to include de novo applications.
The trade group says FDA's recent draft guidance on employing adult device data to help support a pediatric indication should be expanded to include 510(k)s, rather than being limited to PMAs and HDEs.
Vasum Peiris, a pediatric cardiologist, is set to join CDRH in August to guide the center's perspectives on devices that could be used in children.