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Combination Products and Sponsor-Investigator IDE Studies

University of Miami HSRO October 24, 2008. 2. Combination Products - Background. Combination products statutorily recognized in Safe Medical Devices Act of 1990Required assignment to lead center based on primary mode of actionImplemented by Chief Mediator and Ombudsman . University of Miam

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Combination Products and Sponsor-Investigator IDE Studies

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    1. Combination Products and Sponsor-Investigator IDE Studies Stephen P. Rhodes Product Jurisdiction Officer Director, IDE and HDE Programs Center for Devices and Radiological Health University of Miami Human Subjects Research Office (HSRO) Conference October 24, 2008

    2. University of Miami HSRO October 24, 2008 2 Combination Products - Background Combination products statutorily recognized in Safe Medical Devices Act of 1990 Required assignment to lead center based on primary mode of action Implemented by Chief Mediator and Ombudsman

    3. University of Miami HSRO October 24, 2008 3 Office of Combination Products (OCP) Created by Medical Device User Fee and Modernization Act (MDUFMA) Office established on December 24, 2002 OCP given broad oversight responsibilities covering the regulatory life cycle of combination products.

    4. University of Miami HSRO October 24, 2008 4 OCP – Common Questions OCP answers four questions about products: 1. Type of product 2. Lead reviewing Center 3. The review process 4. Minimize review times

    5. University of Miami HSRO October 24, 2008 5 Where is OCP?

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