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If your medical device is already cleared or approved for adults, don't hold your breath waiting for the FDA to clear it for kids.
That's the goal of a new effort led by Children's National Hospital in Washington, DC, and the National Capital Consortium for Pediatric Device Innovation, which is asking medical companies to submit proposals to get devices approved or cleared for use in kids, the Washington Post reports.
"There are already a number of medical devices on the market that have been FDA cleared or approved and proven viable, and this partnership will help provide important evidence generation and other wraparound services to guide device creators through the regulatory path for pediatric labeling," Kolaleh Eskandanian, vice president and chief innovation officer at Children's National, says in a press release.
The goal of the Innovate 4 Kids initiative is to get medical devices approved or cleared based on real-world data instead of the data that comes out of clinical trials.
"Instead of assessing medical devices based on data derived from clinical trials, this pioneering initiative, which brings together a coalition of leading healthcare and academic organizations, is focused on leveraging real-world data (RWD) that can be translated into RWE to gain FDA clearance or approval for use with children," the release says.
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