As per, Pediatric Medical Device Safety and Improvement Act (PMDSIA) of 2007, “If the course of the disease or condition and the effects of the device are sufficiently similar in adults and pediatric patients, the Secretary may conclude that adult data may be used to support a determination of a reasonable assurance of effectiveness in pediatric populations, as appropriate.” The specific threshold for approval addressed under PMDSIA for the use of extrapolated data is “reasonable assurance of effectiveness” but does not address the safety data issue.
This guidance explains when and how existing clinical data in another studied population (such as adults, or a different pediatric sub population) may be leveraged (“extrapolated”) to support marketing approval and labeling of medical devices for use in pediatric patients. The scope of this guidance includes medical devices subject to the PMA, HDE, or de novo premarket requirements where a pediatric indication is sought.
The Food and Drug Administration (FDA) aims to promote safe and effective device use in pediatric patients, while ensuring device approvals are based on valid scientific evidence. Currently, there is a paucity of scientific evidence available to substantiate submissions for devices that are indicated for use in the diagnosis or treatment of pediatric patients. 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. This approach will potentially streamline the process for establishing a pediatric intended use claim, and enhance and encourage pediatric device development programs.
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