Posted by Michael Wonder on 29 Jun 2016
Availability and dissemination of results from US FDA–mandated post-approval studies for medical devices
27 June 2016 - This study analyses the availability of results from post-approval studies of medical devices.
Medical devices present unique challenges to the US FDA approval process owing to their complexity, the learning curve associated with adopting new technology, and short market life compared with drugs.
In 2011 the Institute of Medicine recommended a lifecycle approach highlighting the importance of postapproval studies (PAS). In its efforts to speed patient access to potentially life-saving medical devices, the FDA has been shifting priorities from premarket to postmarket data collection.
Thus, it is important to understand how well PAS are doing at achieving the agency’s goals of assessing safety and effectiveness.
