Left Atrial Appendage Occlusion — Closure or Just the Beginning? Jun 18, 2009
Dr. Maisel is the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center, Boston. This article (10. (New England Journal of Medicine)
House Hears Testimony on Medical Device Bill That Would Reverse Supreme Court Ruling May 14, 2009
The age-old debate over tort law took shape on the Hill Tuesday as a House subcommittee heard testimony on the Medical Device Safety Act of 2009. The bill proposes to overturn the Supreme Court's 2008 ruling in (pdf) which prevents patients injured by certain federally approved medical devices from seeking redress via state product liability suits. (Law.com)
Whats so special about 100 days? Apr 13, 2009
The Food and Drug Administration is revamping its factory inspection policies (for Bush s FDA, manufacturers self-reported) and is considering new rules on medical device safety, at long last. Proposals are being developed in many agencies to enhance our ability to be confident of the products we buy. (Waterloo Courier, IO)
Medtronic Raises Death Estimate Tied to Wires Mar 14, 2009
Those decisions were based on a Supreme Court decision last year that the federal FDA is the final arbiter of medical device safety. Democrats in Congress are currently working to pass legislation to overturn that decision. (ABC News -- Wire)
Definitions of Class I, II, and III recalls Feb 8, 2009
Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls. (U.S. Food and Drug Administration -- Alerts)
