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FDA, Medical Device Industry and NORD Announce New Public-Private Partnership

Monday, December 3, 2012 2:16 PM


First-ever PPP Created to Focus Exclusively on Advancing Medical Device Regulatory Science

WASHINGTON, Dec. 3, 2012 /PRNewswire-USNewswire/ -- Senators Amy Klobuchar and Al Franken joined Food and Drug Commissioner Margaret Hamburg, MD, NORD President Peter L. Saltonstall and others today in a Capitol Hill event to announce the launch of a new public-private partnership aimed at promoting the development of innovative medical devices for patients.

(Logo: http://photos.prnewswire.com/prnh/20110719/DC37656LOGO-b)

The founding members of the new partnership, which will be called the Medical Device Innovation Consortium (MDIC), are LifeScience Alley, a biomedical science trade association; several companies involved in developing medical devices; and NORD (the National Organization for Rare Disorders), in partnership with the U.S. Food and Drug Administration (FDA).

"We at NORD are especially honored to be the first and only patient organization to be invited to be a founding member of the consortium," Saltonstall said in his remarks at the launch today.  "Over the past several years, we have sought to forge a productive relationship with the FDA and the medical devices industry because we believe that progress can be made only if all segments of the medical system work together.  We hope this public-private partnership will serve as a model for additional collaboration."

The mission of MDIC will be to foster innovation, increase the tools available to evaluate new medical devices to assure that they are safe and effective, and ensure that innovative devices get to patients as quickly as possible while still protecting public health.

Speakers at this morning's Capitol Hill announcement, in addition to Saltonstall, included among others:

  • Senator Amy Klobuchar (MN)
  • Senator Al Franken (MN)
  • FDA Commissioner Margaret Hamburg, MD
  • FDA Center for Devices and Radiological Health (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.

    Read FDA's press release about the new partnership.

    Read full text of NORD president's remarks.

    Read about MDIC. 

    SOURCE National Organization for Rare Disorders (NORD)

    (Source: PR Newswire )
    (Source: Quotemedia)

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