FDA Rolls Out Pediatric Info Rule For Device Makers

Law360, New York (April 1, 2010, 5:00 PM EDT) -- The U.S. Food and Drug Administration is implementing a mandate that medical device makers include information in product applications about pediatric patients who have the disease the device is intended to treat.

The rule applies requirements that were passed in 2007 as part of the Food and Drug Administration Amendments Act, the agency said in its announcement Wednesday. It is intended to help the agency better identify and track medical devices that could be used to treat children.

The requirement covers devices that are not developed...
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