FDA has issued a direct final rule that mandates all device manufacturers to provide readily available information in certain premarket applications on pediatric patients who suffer from the disease or condition that the device is intended to treat, diagnose, or cure, even if the device is intended for adult use.
FDA said that very few devices are developed or assessed specifically for use in pediatric patients, those 21 or younger at the time of treatment or diagnosis. The 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 requirements, contained in the FDA Amendments Act of 2007, will also improve the agency’s ability to track the number of approved devices for which there is a pediatric subpopulation who could benefit and the number of approved devices labeled for use in pediatric patients.
According to the FDA, 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. Manufacturers currently 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.
If the manufacturer does not submit such information, the FDA may not approve the application until the required information is provided.
Jeffrey Shuren, director of the Center for Devices and Radiological Health at FDA, said: “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.”