FDA proposal would require pediatric data in submissions

02/21/2013 | Bloomberg BNA (free content)

The FDA has issued a supplemental proposal mandating that medtech firms include data on pediatric patients when applying for premarket approval or a PMA supplement, a humanitarian device exemption request and a product development protocol. The FDA says it incorporated feedback from a related proposal from 2010 that was later withdrawn. The proposal is up for comment through April 22.

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