Zdrowie i gospodarka · 15/09/2011

Announcement of Requirements and Registration for “Reporting Device Adverse Events Challenge”

Medical devices will play an increasingly large role in the monitoring and collection of patient data with the spread of electronic health records. The United States has a limited system for the post- market surveillance of medical devices, specifically as it relates to monitoring product safety and effectiveness. The "Reporting Device Adverse Events Challenge" asks multi-disciplinary teams to develop an application that facilitates the reporting of adverse events related to medical devices, whether implanted or used in the hospital, clinic, or home. The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111- 358).