The U.S. Food and Drug Administration (FDA) will help advance a public-private partnership that will work to give patients quicker access to medical devices. Many manufacturers have complained that the current approval process for allowing medical devices on the market is unnecessarily burdensome. But advances in regulatory schemes – the development of new tools and [...]
FDA Proposes Rule on Medical Device Identifier
July 10, 2012 By Leave a Comment
The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would require manufacturers to place a unique device identifier (UDI) on medical devices, with the aim to facilitate the reporting of adverse events related to those devices so that the agency could address them more quickly, including possible recalls. The UDI would [...]
Medical Device Association Concerned U.S. Will Lose Lead
June 10, 2011 By 1 Comment
The medical device industry association has called on the White House to create an innovations office. In a recent policy agenda, the “Competitiveness Agenda” released by the Advanced Medical Technology Association’s (AdvaMed), the idea of an innovations office was among other proposals, such as increased basic research funding and shortening of the U.S. Food and [...]
GAO Concerned About Medical Device Approval Process
April 20, 2011 By Leave a Comment
The Government Accountability Office (GAO) has raised concerns about the approval process that high-risk medical devices undergo — or rather, don’t undergo — by the U.S. Food and Drug Administration (FDA). The federal watchdog group says the agency recently took steps to see if certain high-risk medical devices, such as artificial hips and external defibrillators, [...]
