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An investigational device exemption (IDE) allows an investigational device (i.e. a device that is the subject of a clinical study [1]) to be used in order to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to Food and Drug Administration (FDA). [2]
A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed without requiring evidence of effectiveness. The FDA calls a device approved in this manner a "Humanitarian Use Device" (HUD).
In December 2023, during a visit to the United States, Romanian Prime Minister Marcel Ciolacu said that Romania's entry into the U.S. visa-free program would be announced in 2024, ahead of the 2025 deadline discussed with the U.S. representatives. [80] On January 10, 2025, it was announced Romania would join the VWP on March 31, 2025. [81]
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Three teens face charges after a Marta bus driver, identified as Leroy Ramos, was killed, officials say.
A 40-year tax exemption for the medical building. Under Chapter 121A of state law, developers in urban renewal areas, such as downtown Quincy, receive 15-year exemptions from real estate and ...
Different kinds of sun protection film on a glass ceiling. A window film, sometimes called tint, is a thin laminate film that can be installed on the interior or exterior of glass surfaces in automobiles and boats, and as well as on the interior or exterior of glass in homes and buildings.