The guidance stems from FDA’s concerns over the quality of scientific evidence used to substantiate pediatric medical device submissions. The agency outlines ways in which device makers can extrapolate data to ensure devices can be used for younger populations.
“For the purposes of this document, ‘extrapolation’ refers to the leveraging process whereby an indication for use of a device in a new pediatric patient population can be supported by existing clinical data from a studied patient population,” the report explains.
Like the draft guidance, which was issued in May 2015, the final guidance focuses on four main objectives:
- To increase the amount of safe and effective pediatric devices by providing a roadmap for leveraging relevant clinical data that proves the safety and efficacy of the devices.
- To detail appropriate circumstances for leveraging this data to support pediatric device indications and labeling.
- To outline the approach the FDA uses to determine whether the data extrapolation is appropriate.
- To describe statistical methodology that can be used to leverage the data to increase the precision of pediatric inferences.
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