June 13th - The Ritz-Carlton, Washington, DC
There is a critical unmet need in the U.S. and around the world for the development of pediatric medical devices, with support coming only from a scarce number of available grants and some private investments and philanthropy. The testing and marketing of new devices for children raise unique challenges as well. Finally, there has been much controversy around the 510(k) process for device approvals, which leads to additional need for new innovative approaches that improve the regulatory pathways for medical device development.
As we shift to a value-based healthcare system, regulatory bodies, innovators, and manufacturers must find the right balance between two noble goals: encouraging and enabling innovative medical advancements and ensuring that patients receive treatment that is as safe and effective as possible.
Please join us on June 13, 2013, for a day long symposium with leaders from the FDA, NIH, IOM, and industry, as well as policymakers, clinicians, lawyers, scientists, and bioethicists from around the world to discuss these critical issues in pediatric surgical innovation and device development.