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.
The new rule takes effect April 10, 2014, according to a notice in the Federal Register, at which point medial device makers will be required to "include, if readily available, a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure, and the number of affected pediatric patients."
The FDA will need that data to compile an annual report that it’s required to submit to Congress, the agency said. The rule applies to requests for humanitarian device exemption, premarket approval applications and supplements and product development protocols submitted after the effective date.
Failing to provide the necessary information may result in refusal to approve the new technology, the FDA warned. The agency plans to contact applicants who have insufficient information and to work with companies to get them up to speed on the new pediatric data requirement. For companies whose applications are lacking only the pediatric info, the FDA plans to issue "approvable" letters that recognize the validity of the application in general and to request the missing information.