Devices

Guidance on Leveraging Data for Pediatric Device Use

FDA has released a final guidance on “Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices” that seeks to provide clarity and predictability for device sponsors on specific criteria that should be considered when deciding whether leveraging existing clinical data to support pediatric claims is appropriate. When considering extrapolation, the guidance encourages sponsors to engage FDA early in product development planning.

“Leveraging relevant available clinical data, when appropriate, may lead to more devices being granted marketing authorization for pediatric indications, which will increase the availability of medical devices with appropriate labeling to support safe and effective device use in pediatric patients,” the document says. “This approach will potentially streamline the process for establishing a pediatric intended use claim, and enhance and encourage pediatric device development programs.”

The guidance says that allowing extrapolation largely depends on three main factors: (1) the similarity of the existing adult response data or population characteristics to the intended pediatric sub-population; (2) data quality in terms of study design, data collection, and measurement; and (3) whether extrapolated data may be used to fairly and responsibly decide whether there is a reasonable assurance of the device’s safety and effectiveness. “When both similarity and quality are determined to be sufficiently high, there is a greater level of certainty that the existing data can be appropriately considered for extrapolation to the intended pediatric subpopulation,” it says. “If neither similarity nor data quality are high, then the existing adult data may be inappropriate to use for extrapolation purposes.”

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