The U.S. Food & Drug Administration (FDA) just announced that it is now requiring <"https://www.yourlawyer.com/practice_areas/defective_medical_devices">medical device manufacturers to include information on pediatric populations, applying requirements in the 2007 FDA Amendments Act.
The agency will begin implementing a requirement that device manufacturers provide readily available information in certain pre-market 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.
Of note, very few devices are developed or assessed specifically for use in pediatric patientsâ€”children aged 21 and youngerâ€”at the time of treatment or diagnosis. The FDA is taking this step in an effort to 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 agencyâ€™s ability to track the number of approved devices for which there is a pediatric subpopulation who could receive a benefit, as well as the number of approved devices labeled for use in pediatric patients.
â€œThis 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,â€ said Jeffrey Shuren, M.D., director of the FDAâ€™s Center for Devices and Radiological Health.
Under the 2007 legislation, manufacturers must provide certain pediatric information, if readily available, with each pre-market approval application or supplement, humanitarian device exemption request, or product development protocol. Manufacturers now must include a description of any pediatric subpopulations who 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.
Of note, we have also been following the issues concerning the lack of pediatric studies concerning medications and also recently wrote about a study published this year that confirms that medications routinely prescribed to pediatric patients are not always approved for children and teens. Testing of medical devices and medications on children is problematic since good ethical practice requires informed consent from people participating in clinical trials, something not always feasible with children, especially very young children.