The U.S. Food and Drug Administration announced today that will begin implementing a requirement that device manufacturers 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.
Very few devices are developed or assessed specifically for use in pediatric patients, those 21 or younger at the time of treatment or diagnosis. 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 requirements, contained in the Food and Drug Administration 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.
“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.
Link this story to your website:
Copy the above code and paste it into your webpage, blog or forum
Be the first one to comment on this news