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Federal Partners Resources
Centers for Medicare & Medicaid Services
- CMS and FDA have parallel review of certain FDA premarket review submissions for medical devices and CMS national coverage determinations.
CMS encourages innovators to meet "early and often" when applying for Medicare reimbursement for new technologies to better understand
the data needed for a successful reimbursement review.
FDA Center for Biologics Evaluation and Research (CBER)
- CBER regulates a complex set of products, including cell and gene therapies, blood and blood components, vaccines, tissues,
xenotransplantation products, and allergenic products. CBER interacts with product sponsors throughout the product lifecycle from development
through the post-marketing phase, and offers online resources on the CBER regulatory process.
FDA Center for Drug Evaluation and Research (CDER)
- CDER support offers assignment of a regulatory project manager, holding meetings at different points in the development process, even before
identifying a lead compound and then later to facilitate IND filing; providing information about approval requirements; and giving advice based
on past review experience.
National Science Foundation (NSF) Innovation-Corps (I-Corps) Program
- The primary goal of NSF's I-Corps program is to foster entrepreneurship that will lead to the commercialization of technology that
has been supported previously by NSF-funded research. I-Corps Teams consist of the principal investigator, an entrepreneurial lead, and a mentor.
Non Federal Partners Resources
- Kaiser Permanente is one of the prototype accountable care organizations, with the greatest number of members in California,
but members also in Hawaii, Oregon, Colorado, Georgia, and the Mid-Atlantic, for a current total of 9.2 million members with a large
Medicare population. Approvals for a new technology are dependent on a Kaiser Permanente physician determining it is reasonable and necessary.
Resources include 10 years of online medical records and a venture fund.