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The Food and Drug Administration (FDA)'s Center for Devices and Radiological health (CDRH) recently launched the READI-Home (Reducing Readmissions through Device Innovation for the Home) Innovation Challenge, part of its broader Home as a Health Care Hub initiative, to accelerate development of
In Merck KGaA v. Integra Lifesciences I, Ltd., 125 S. Ct. 2372 (Jun. 13, 2005), the Supreme Court considered the scope of the exemption from patent infringement embodied in 35 U.S.C. § 271(e)(1). Under §271(e)(1), also referred to as the safe harbor provision, "[i]t shall not be an act of