Regulatory

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  • Oct 15, 2013
    Commentary

    Device tax repeal still possible, Senator Daschle tells Cleveland Clinic audience

    Washington came to Cleveland last night in the form of Senator Tom Daschle (D-SD), who told an audience of healthcare executives, investors, and analysts, that while repeal of the medical device tax may be “off the table” for now, that could change. Addressing a dinner audience at The Cleveland Clinic’s Innovation Summit on “Obesity, Diabetes and the Metabolic Crisis” on Day 14 of the government shutdown and about 48 hours before the country reaches the debt ceiling, the former US Senate Majority Leader said, “With so much bipartisan support in Washington, this issue could continue to reappear and resurface as we consider long-term issues and options moving forward.”...More
  • Aug 20, 2013
    Commentary

    Speak your mind to FDA leaders

    Perhaps you’ve been surprised by the FDA review process and you have some questions about how it works and what is being done to improve communications between the agency and device makers. Or maybe you want to know more about FDA recommendations for cybersecurity practices and policies pertaining to medical device in order to prevent unauthorized access or modification to devices. Whatever FDA-related medtech issues are on your mind, a special Town Hall Meeting at next month’s AdvaMed 2013 conference in Washington will provide you the opportunity to pose your questions to five FDA leaders, face-to-face. The interactive panel session will be held September 25, 2:15-3:30 pm, and will include . . ....More
  • Jul 19, 2013
    Commentary

    House legislation would make user fees exempt from sequestration

    Legislation that would exempt FDA user fees from cuts under sequestration was introduced this week in the House. Medical Design joins AdvaMed in praising Reps. Leonard Lance (R-NJ), Anna Eshoo (D-CA), Doris Matsui (D-CA), Mike Rogers (R-MI) and the other co-sponsors of this legislation, which will let FDA to have full access to the user fees paid by medical technology companies and other FDA-regulated industries....More
  • Mar 22, 2013
    Commentary

    User fee access safe for now; sequester still needs to be addressed

    The Senate approved this week a continuing resolution (CR) that preserves House-passed language correcting an anomaly in the current CR that would have barred FDA from spending $40 million of the fees it is collecting from device and diagnostics companies....More

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