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Abstract
The fact that translation of biomedical optical imaging modalities is relatively untraversed territory from start to finish is a major theme of this book. Despite the lack of translational activity by the optical imaging community, the translational pathway is far from uncharted. The 21 CFR (Code of Federal Regulations) governs procedures and actions to be taken by individuals and institutions interested in commercializing drugs or medical devices within the United States. These regulations apply to all biomedical optical device technologies and therefore represent fixed markers along the pathway to translation for any emerging biomedical imaging technology. While these regulations are in place for the researchers to follow, their main purpose is to protect the consumer. As a result, the total array of regulatory signposts is often confusing and burdensome to the researchers, creating more of a barrier than a pathway for translational research. As mentioned in the previous chapter, the NTR was formed in 2008 as a team approach to test academic methods to navigate these barriers in an attempt to bring new biomedical imaging technologies closer to the endpoint of FDA approval and product commercialization.
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CHAPTER 3
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