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Humanitarian Device Exemption. 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).
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. ยง 360bbb-3, to allow the use of a ...
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]
ISO 10993. The ISO 10993 set entails a series of standards for evaluating the biocompatibility of medical devices to manage biological risk. These documents were preceded by the Tripartite agreement and is a part of the international harmonisation of the safe use evaluation of medical devices. [1] For the purpose of the ISO 10993 family of ...
Global Medical Device Nomenclature ( GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
List of counties in Ohio. There are 88 counties in the U.S. state of Ohio. Nine of them existed at the time of the Ohio Constitutional Convention in 1802. [1] A tenth county, Wayne, was established on August 15, 1796, and encompassed roughly the present state of Michigan. [2] During the Convention, the county was opposed to statehood, and was ...
Ohio Revised Code. The Ohio Revised Code (ORC) contains all current statutes of the Ohio General Assembly of a permanent and general nature, consolidated into provisions, titles, chapters and sections. [1] However, the only official publication of the enactments of the General Assembly is the Laws of Ohio; the Ohio Revised Code is only a reference.
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...