FDA Requires OEMs to Include Pediatriac Info in Premarket Applications

The U.S. Food and Drug Administration (FDA) will begin implementing a requirement that calls for medical device manufacturers to provide information in certain premarket applications on pediatric patients who suffer from the disease or condition for which the device is intended, the agency said.

This effort will provide a better understanding of which devices developed for use in adults should be assessed or modified for use in pediatric populations, the FDA said.

The requirements are contained in the FDA’s Amendments Act of 2007.

Under the 2007 legislation, manufacturers must provide certain pediatric information, if readily available, with each premarket approval application or supplement, humanitarian device exemption request, or product development protocol, according to the FDA.

Manufacturers now must include a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure. Manufacturers also must include the number of affected pediatric patients.

“This requirement allows the agency to collect information that will help us better assess public health needs for medical devices that can be used for pediatric populations,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.