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http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHInnovation/InnovationPathway/default.htm?source=govdelivery&utm_campaign=HomePageSpotlight&utm_content=f2&utm_medium=website&utm_source=fda&utm_term=InnovationPathway