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The FDA issues a final rule requiring that new medtech applications include data on potential pediatric patients.

The FDA this month finalized a rule requiring more pediatric patient information from medical devices going through the premarket approval pathway, even if the products are intended for adults.

The requirement, part of the Food & Drug Administration Amendments Act passed in 2007, aims to improve the identification of devices that could be used to treat children and to enhance the agency's ability to track devices approved for use in pediatric patients.

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