Wednesday, 11/30/2022

Partner Resources

Federal Partners Resources

Centers for Medicare & Medicaid Servicesimage of external link icon - 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)image of external link icon - 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 Devices and Radiological Health (CDRH)image of external link icon - CDRH offers pre-submission meetings, early feasibility guidance for devices, and welcomes collaborations with companies in early feasibility studies.
FDA Center for Drug Evaluation and Research (CDER)image of external link icon - 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.
Intellectual Property Assessment Tool (United States Patent and Trademark Office)image of external link icon - This online tool provides personalized training resources for small and medium sized enterprises and inventors.
National Science Foundation (NSF) Innovation-Corps (I-Corps) Programimage of external link icon - 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 Permanenteimage of external link icon - 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.

Last Updated January 2014