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June 2012 Archives

Sapien-Transcatheter-Heart-Valve.jpg
mjlst-logo-button.pngMJLST faculty editor-in-chief Ralph Hall and Andrew Von Eschenbach, former commissioner of the U.S. Food and Drug Administration (2005-2009), wrote an opinion piece in the June 18 Wall Street Journal on ways to move medical devices more quickly into the hands of health care practitioners. They cite the example of the American-made SAPIEN Transcatheter Heart Valve (pictured right) that was available to patients in Europe four years before those in the United States. Read "FDA Approvals Are a Matter of Life and Death" (WSJ). (NOTE: the WSJ article can be viewed in full by using Google to search "FDA Approvals Are a Matter of Life and Death" and then clicking the first link to WSJ in the results.).

In a related article in MJLST issue 13.1, Professor Hall and Eva Stensvad outlined problems with the 510(k) medical device clearance process and argued that while the Institute of Medicine (IOM) is generally an invaluable policy resource, invaluable policy resource, its Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process is not fairly balanced and unable to fairly and accurately perform its duties. Read: Left to Their Own Devices: IOM's Medical Device Committee's Failure to Comply.