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Health Care Reforms Target Medical Devices

Executive Summary

Welcome to 2009. If you haven't been paying attention to the health care happenings in the nation's capital this year, you should be. The President and powerful members of Congress have put themselves on the line to remake the US health care system; whistleblowers within FDA's device review office are charging management with breaking the law; federal mandates for more transparency in doctor-manufacturer relationships have become the lesser of evils for many in industry; and one of the most significant device-specific US Supreme Court decisions in recent memory has become a vulnerable target of leading Democratic lawmakers. As Steve Ubl, president and CEO of AdvaMed, recently observed, "What happens over the next 25 weeks could affect the industry over the next 25 years."

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