The Medical Device Initiative seeks to improve the tracking of medical device safety and to foster innovation that benefits patients through streamlined device approvals. http://www.pewtrusts.org/news_room.aspx The U.S. Food and Drug Administration announced last month that it will classify metal-on-metal hip implants as high-risk devices. That comes after the artificial joints were found to have failed at high rates, causing disability and meaning additional surgery for thousands of people. Wed, 27 Feb 2013 17:30:24 GMT http://www.pewtrusts.org/news_room_detail.aspx?id=85899454931&WT.rss_ev=f&WT.rss_f=Medical Device Initiative&WT.rss_a=The Loophole That Keeps Precarious Medical Devices in Use&WT.z_contenttype=PewInTheMedia An editorial in the Minneapolis Start Tribune praises bipartisan work on the drug and device reform bill recently passed by the U.S. Congress. Tue, 03 Jul 2012 17:00:00 GMT http://www.pewtrusts.org/news_room_detail.aspx?id=85899403242&WT.rss_ev=f&WT.rss_f=Medical Device Initiative&WT.rss_a=Editorial: Drug, Device Reform Gets Bipartisan Push&WT.z_contenttype=NewsArticle Josh Rising, Medical Device Initiative Project Director, is quoted in a U.S. News and World Report article about the safety of metal-on-metal hip implants. Thu, 28 Jun 2012 09:45:00 GMT http://www.pewtrusts.org/news_room_detail.aspx?id=85899401983&WT.rss_ev=f&WT.rss_f=Medical Device Initiative&WT.rss_a=FDA Probing Safety of Metal-on-Metal Hip Implants&WT.z_contenttype=NewsArticle In an article about Senate passage of the FDA user fee bill, the Associated Press quotes Allan Coukell, director of medical programs at Pew Health Group, on the significance of the foreign drug manufacturing facility inspection provisions in the bill. Wed, 27 Jun 2012 08:00:00 GMT http://www.pewtrusts.org/news_room_detail.aspx?id=85899401633&WT.rss_ev=f&WT.rss_f=Medical Device Initiative&WT.rss_a=FDA User Fee Bill Gives Agency New Powers to Inspect Overseas Prescription Drug Plants&WT.z_contenttype=NewsArticle The U.S. Senate today joined the House in passing Food and Drug Administration Safety and Innovation Act (S. 3187), a bill to support the U.S. Food and Drug Administration’s drug and device reviews. Tue, 26 Jun 2012 20:00:00 GMT http://www.pewtrusts.org/news_room_detail.aspx?id=85899401007&WT.rss_ev=f&WT.rss_f=Medical Device Initiative&WT.rss_a=Pew Commends U.S. Congress for Passing FDA User Fee Legislation&WT.z_contenttype=PressRelease Allan Coukell, deputy director of the Medical Safety Portfolio of the Pew Health Group, talks about drug safety on C-SPAN. Tue, 26 Jun 2012 09:45:00 GMT http://www.pewtrusts.org/news_room_detail.aspx?id=85899401346&WT.rss_ev=f&WT.rss_f=Medical Device Initiative&WT.rss_a=Pew's Allan Coukell Discusses FDA Reform Act of 2012&WT.z_contenttype=PewInTheMedia The de novo process as it exists now is not achieving its purpose of streamlining the path to move new devices onto the marketplace and has instead added unnecessary and time-consuming requirements. Mon, 25 Jun 2012 09:45:00 GMT http://www.pewtrusts.org/news_room_detail.aspx?id=85899400999&WT.rss_ev=f&WT.rss_f=Medical Device Initiative&WT.rss_a=Facilitating Medical Device Innovation: De Novo Reform&WT.z_contenttype=FactSheet In 2008, the Food and Drug Administration (FDA) launched the Sentinel Initiative, a national electronic system designed to “track the safety of drugs, biologics, and medical devices once they reach the market.” By proactively monitoring data from electronic health records and other sources rather than relying on spontaneous reporting from manufacturers and health care providers, the Sentinel system can more quickly identify safety issues. Mon, 25 Jun 2012 09:10:00 GMT http://www.pewtrusts.org/news_room_detail.aspx?id=85899400991&WT.rss_ev=f&WT.rss_f=Medical Device Initiative&WT.rss_a=Improving Medical Device Safety Through Better Surveillance&WT.z_contenttype=FactSheet A blog post in The Hill about the passage of legislation by the House that reauthorizes the FDA's user-fee program for brand-name drugs and medical devices and also expands the program. Thu, 21 Jun 2012 10:30:00 GMT http://www.pewtrusts.org/news_room_detail.aspx?id=85899400334&WT.rss_ev=f&WT.rss_f=Medical Device Initiative&WT.rss_a=House Cheers, Approves FDA Reform Bill&WT.z_contenttype=NewsArticle Terms and Conditions Page http://www.pewtrusts.org/terms_and_conditions.aspx