Medical Device Law Update - December 2012: FDA and Industry Form “Consortium” to Improve Device Approval Process

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In response to wide criticism of the Food and Drug Administration’s (FDA) current review process, leaders of industry, academia and government have joined forces to create the Medical Device Innovation Consortium (MDIC), an independent, nonprofit organization aimed at advancing the development and approval of new medical devices. MDIC’s primary goal is to share ideas, resources and funding to create scientific tools that will help develop and evaluate the safety and effectiveness of new devices more efficiently and at a lower cost.

 

The creation of this public-private partnership is part of a broader effort to improve both innovation by device companies in the United States and the safety assessment of devices by the FDA.  The MDIC’s objectives include enhancing the quality and performance of medical devices, improving the timeline of approval of devices, and preparing new methods and tools that will improve the transparency and effectiveness of the overall process.  This effort to simplify the process for medical device development and approval will have a profound impact on medical device companies, many of which are small businesses that often collapse in the current convoluted, burdensome and unpredictable system.

 

Initial industry members include Medtronic (which has loaned one of its vice presidents to serve as executive director of the MDIC), Abiomed, CVRx, Boston Scientific, ImmuCor, Cyberonics, Terumo BCT, and MichBio.  Government members consist of the FDA’s Center for Devices and Radiological Health as well as the Centers for Medicare and Medicaid Services.  The Pew Charitable Trust, National Association of Rare Disorders, and LifeScience Alley, the Minnesota trade association that led the creation of MDIC, are participating nonprofit organizations. The Mayo Clinic and the University of Minnesota will represent academia.

 

The MDIC is the first of its kind in regulatory science.  Depending on its accomplishments for the medical device industry, it may serve as a model for additional public-private partnerships throughout the regulatory science field.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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