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A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
Class I devices are subject to the least regulatory control. Class I devices are subject to "General Controls" as are Class II and Class III devices. [9] [7] [6] General controls are the only controls regulating Class I medical devices. They state that Class I devices are not intended to be: For use in supporting or sustaining life;
"Health Care: Federal Regulation of Medical Devices--Problems Still To Be Overcome" (PDF). gao.gov. U.S. Government Accountability Office. September 30, 1983. OCLC 226405143. "Medical Devices: FDA's 510(k) Operations Could Be Improved" (PDF). gao.gov. U.S. Government Accountability Office. August 17, 1988. OCLC 18759600
ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Medical device cannot be classified as a class I device because the controls authorized are insufficient to provide reasonable assurance of the safety and effectiveness of the device. Medical device has sufficient information to establish a performance standard and it is necessary to establish a performance standard for the device.
Medical devices first came under comprehensive regulation with the passage of the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C), [9] which replaced the earlier Pure Food and Drug Act of 1906. The FD&C allowed the FDA to perform factory inspections and prohibited misbranded marketing of cosmetic and therapeutic medical devices. [10]
The Final Rule on Unique Device Identifiers also mandates medical device manufacturers to make a submission to the FDA's Global Unique Device Identification Database. The submission to the GUDID will include the Primary Device Identifier portion of the UDI as well as associated data attributes about each model or version number of the device.