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FDA, Medical Device Industry and NORD Announce New Public-Private Partnership
Date:12/3/2012

alth (CDRH) Director Jeffrey Shuren, MD, JD
  • Centers for Medicare and Medicaid Services, Deputy Director, Coverage and Analysis Group Tamara Syrek Jensen, JD
  • Immucor Inc. CEO William Hawkins
  • LifeScience Alley President and CEO Dale Wahlstrom
  • In his remarks, Saltonstall said that NORD's role would be to provide the patient perspective in the new partnership.  Noting that only about 250 of the nearly 7,000 rare diseases have treatments, he said that NORD's "highest priority is to help create and encourage an environment in which new treatments can be developed and made available to patients.

    "We hope and expect that this new consortium will make an important contribution in addressing some of the strategic needs of the medical devices industry," Saltonstall added.  "A robust industry and an efficient and transparent FDA are absolutely essential to the development of innovative new treatments."

    MDIC will draw together experts from FDA, the medical device industry, academia and related organizations to improve health through the application of shared knowledge.  Specific goals include:

    • To ensure that innovative technology is readily available to U.S. patients
    • To make the medical device regulatory process more expeditious, transparent and effective
    • To reduce the risk and expense of clinical research and
    • To reduce the time and cost of medical device development.

    SOURCE National Organization for Rare Disorders (NORD)
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