Encouraging Research and Development of Pediatric Medical Devices Through Legislative and Regulatory Action: The Pediatric Medical Device Safety and Improvement Act of 2007 in Context

摘要

In September 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA). Title III of the FDAAA, the Pediatric Medical Safety and Improvement Act (Title III), created new incentives, mandates, Food and Drug Administration (FDA) authority and funding with the aim of increasing the availability of devices for pediatric populations while assuring the safety and effectiveness of those devices. This article describes the complex problem Title III addresses and situates Title IIIwithin the context of the regulatory scheme previously in place, particularly in relation to the regulatory scheme addressing the parallel problem for pediatric drugs, and the concerns and policy recommendations of diverse stakeholders voiced leading upto Title III.