Industry Largely Supports FDA’s New Proposal On Pediatric Data Submission
This article was originally published in The Gray Sheet
Device companies are generally happy with FDA’s rewrite of a rule requiring information on pediatric populations suffering from conditions their devices are intended to treat. The American Academy of Pediatrics is less pleased.
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The agency issued its final guidance April 30 on reporting “readily available” information on pediatric subpopulations in device submissions. As with the 2013 draft version, it backs off on a pre-draft proposed rule that would have asked firms to provide data on potential, or possible, pediatric uses of devices.
One of FDA’s New Year’s resolutions seems to be emphasizing pediatric device development, as seen in a recent final rule on capturing data on pediatric use of devices, as well as a forthcoming draft guidance on pediatric uses of medical devices.
FDA has 1withdrawn a new regulation that would have required companies to submit additional pediatric patient data as part of pre-market submissions beginning next month, but says it hopes to finalize a possibly revised version soon