July 23, 2008
Pediatric medical devices are used to diagnose and treat diseases and conditions for children (up to age 21 years). Although some products are designed exclusively for children, other devices are borrowed from adult applications. Because children are often smaller, more active, and have different body structures and functions, designing pediatric medical devices may be very difficult and challenging. Also, because a child’s body changes greatly during childhood, implanted materials raise concerns about long-term exposure to certain equipment and about device longevity.
In September of 2007, congress passed the FDA Amendments Act, legislation that included Title III: Pediatric Medical Device Safety and Improvement Act, which requires that an application or protocol submitted to the FDA for a medical device must include a description of any pediatric subpopulations that suffer from the condition the device will treat, diagnose, or cure. The legislation intends to ensure that pediatric studies and availability of quality product data are considered in new product labeling to ensure pediatric safety and emerging safety issues that occur once a product is used in broad pediatric populations.
The Act also requires that the DHHS Secretary submit a plan to congress related to expanding research and efforts related to pediatric device development. The purpose of this workshop is to gather feedback and information from the research community and the public to help inform the Secretary’s plan.
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