FDA Withdraws Pediatric Data-Submission Rule, But Aims To Regroup Shortly
This article was originally published in The Gray Sheet
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
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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.
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.
The Feb. 19 proposed rule implements requirements from the Pediatric Medical Device Safety and Improvement Act – passed as part of the 2007 FDA Amendments Act. The rulemaking was held up by concerns expressed by industry, which appear to have been addressed by the agency.