Technology Commercialization

Flowchart: Approval Path Alternatives

The simplified flowchart below represents the alternative regulatory pathways available for seeking U.S. FDA clearance, or approval,FDA logo2 of medical device products associated with varying degrees of risk. For information on how products are assigned to a particular risk classification, go to FDA Medical Device Classifications.

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Flowchart: Approval Path Alternatives

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About The Proof of Concept Institute, Inc.

The Proof of Concept Institute, Inc. is a California 501(c) (3) non-profit corporation, whose mission is to develop educational materials and programs for research scientists, clinicians, and engineers that will facilitate more efficient transfer of public-funded (university and federal laboratory) technology and intellectual property to the private sector, where products and services can be developed for the common good and to support U.S. global competitiveness.

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UC San Diego Research Affairs
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Email: innovation@ucsd.edu

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