Washington Roundup


  • FDA Starts Submission Tracker Program

    The U.S. Food and Drug Administration (FDA) has been developing a pilot program aimed at making it easier for medical device companies to see, at a glance, how their device is progressing through the agency’s regulatory processes. The initiativ…
    09.15.15

  • Education Program for Startups Begun by FDA, Fogarty Institute

    The Fogarty Institute for Innovation, a nonprofit that provides intellectual, physical and financial resources to medtech startups, has signed an agreement with the U.S. Food & Drug Administration (FDA) to help educate early-stage companies on th…
    09.15.15

  • NuVasive Reaches Agreement with the Department of Justice

    Officials with San Diego, Calif.-based spine firm NuVasive Inc. reported the conclusion of an ongoing investigation by the U.S. Department of Justice. The company also reported that it has reached a definitive settlement with the U.S. Department o…
    09.15.15

  • FDA Report Points to Possible Risks of Robotic Surgery

    Robotic surgeons were involved in the deaths of 144 people between 2000 and 2013, according to records kept by the U.S. Food and Drug Administration (FDA). And some forms of robotic surgery are much riskier than others: the death rate for head, neck,…
    09.15.15

  • Senate Bill Aims to Speed Up FDA’s Medical Device Review Process

    U.S. Sens. Richard Burr (R-N.C.) and Al Franken (D-Minn.) have introduced bipartisan legislation designed to expedite the medical device approval process. According to a news release from Burr’s office, the FDA Device Accountability Act (The D…
    08.05.15

  • New Draft of 21st Century Cures Legislation Now Available

    Lawmakers in the U.S. House of Representatives released a new “discussion draft” on April 29 of the “21st Century Cures” legislation. The proposal would make legislative changes to the medical device and drug development and d…
    Christopher Delporte, Editorial Director 05.27.15

  • FDA Releases New Guidance on Patient Preference Information In Device Approvals

    In a continued effort to give patients more of a voice in medical device development, the U.S. Food and Drug Administration (FDA) has issued a new draft guidance that outlines ways patient preference information (PPI) might be collected and used in d…
    05.27.15

  • New Congress Comes Out Swinging at the Medical Device Tax

    With Republicans firmly in control of both houses of Congress, a renewed move for repeal of the medical device tax wouldn’t be long in the making. In fact, it took less than a day for members of the 114th Congress to dust off the repeal issue, w…
    Christopher Delporte, Editorial Director 02.18.15

  • FDA Commissioner Resigns

    Margaret Hamburg, M.D., who as commissioner of the U.S. Food and Drug Administration (FDA) for nearly six years has overseen public health initiatives ranging from tobacco control and food safety to personalized medicine and drug approvals, is resign…
    Christopher Delporte, Editorial Director 02.18.15

  • Device Industry Posts Fewest Recalls in Two Years

    The medical device industry experienced its lowest number of medical device recalls since 2012, according to new research from Stericycle, a medtech industry recall consultancy. In total, 275 recalls occurred, including devices from 148 differen…
    09.16.14

  • Social Media and Device Reviews: FDA Releases Draft Guidances on Social Media Usage

    The U.S. Food and Drug Administration (FDA) has released two long-awaited draft guidances for how medical device and pharmaceutical companies should discuss their products online and, in particular, on social media. “These documents strive t…
    08.04.14

  • FDA to Expedite Medical Device Approvals The U.S. Food and Drug Administration (FDA) has unveiled

    FDA to Expedite Medical Device Approvals The U.S. Food and Drug Administration (FDA) has unveiled a proposal designed to speed up development and approval of medical devices that treat life-threatening diseases and debilitating conditions. Under t…
    05.19.14

  • FDA’s Regulation-Making Process Lacks Efficiency, Transparency, Study Claims

    The U.S. Food and Drug Administration (FDA) takes an average of 7.3 years to finalize rules that determine its regulation process, a study has found. Rules associated with cost-benefit analyses take the longest to review, and longer review times of…
    05.19.14

  • More Women Needed in Post-Approval Studies

    The U.S. Food and Drug Administration (FDA) is mandating the inclusion of women in post-approval studies (PAS) for medical devices. According to FDA officials, female participation is necessary to reduce any gender bias related to safety and effect…
    05.19.14

  • AdvaMed Appoints New VP of Government Affairs

    The Advanced Medical Technology Association (AdvaMed) has expanded its executive ranks. The Washington, D.C.-based advocacy group has hired Riley Swinehart as vice president of government affairs. “We’re pleased to welcome Riley to A…
    05.19.14

  • AdvaMed Brass Discusses 2014 Objectives, New Device Tax Survey

    The Advanced Medical Technology Association (AdvaMed) has fired the latest volley in its assault against the 2.3 percent medi
    Christopher Delporte 04.02.14

  • New Angle: Medical Device Tax Repeal Tied to Jobless Benefits?

    Lawmakers have been sparring over reinstating expired jobless benefits. On Jan. 17th, Congress recessed for a week-long break without any resolution to the impasse, which impacts benefits for 1.3 million Americans who have been out of work for…
    02.18.14

  • State Spotlight: S.C. Lawmaker Aims to Ease Tax Burden

    The 2014 elections are still nine months away, but Bakari T. Sellers already is distancing himself from the president and his controversial healthcare law. The Democratic state representative in South Carolina has co-sponsored a bill with Republ…
    02.18.14

  • OIG Finds POD-Supplied Spinal Devices Boost Cost of Surgery Nearly one in five devices used in sp

    OIG Finds POD-Supplied Spinal Devices Boost Cost of Surgery Nearly one in five devices used in spinal fusion surgery in 2011 were supplied by physician-owned distributorships, also called PODs, and while these products resulted in a lower number o…
    11.18.13

  • Senate Bill Aims to Protect Device User Fees from Sequestration

    On Aug. 1, legislation was introduced in the U.S. Senate to help save millions of dollars allocated to the U.S. Food and Drug Administration (FDA) from budget cuts mandated by sequestration. The bill, if passed, would allow the agency to use indu…
    09.24.13