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Clinical devices and technologies are generally governed by the Food and Drug Administration (FDA), [3] National Fire Protection Agency (NFPA) particularly NFPA 99 and chapter 7, [4] NFPA 70, [5] Life Safety Code 101, [6] Code of Federal Regulations (CFR) 21, [7] Occupational Safety and Health Administration (OSHA), [8] The Joint Commission ...
Every medical treatment facility should have policies and processes on equipment control and asset management. Equipment control and asset management involves the management of medical devices within a facility and may be supported by automated information systems (e.g., enterprise resource planning (ERP) systems are often found in U.S. hospitals, and the U.S. military health system uses an ...
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In addition, because biomedical engineers often develop devices and technologies for "consumer" use, such as physical therapy devices (which are also "medical" devices), these may also be governed in some respects by the Consumer Product Safety Commission. The greatest hurdles tend to be 510K "clearance" (typically for Class 2 devices) or pre ...
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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
The Medical Device User Fee and Modernization Act of 2002 was created to speed up the FDA's approval process of medical technology by introducing sponsor user fees for a faster review time with predetermined performance targets for review time. [60] In addition, 36 devices and apps were approved by the FDA in 2016. [61]