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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.
De novo devices require a less rigorous FDA regulatory process [5] and the FDA treats de novo devices like class I and II devices. [5] Class III devices with predicates. Class III devices with predicates (devices with a substantially equivalent device already on the market) are reclassified as class I or II devices. [5] This is done through a ...
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. [2]
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as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
"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
The MDA established a risk-based framework for the classification of medical devices and a regulatory pathway for medical devices to get to the market, created a regulatory pathway for medical device clinical trials, and established several post-market requirements including manufacturer registration and device listing with the FDA, good ...
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.
If it is unclear in which category a device falls, consulting device-specific guidances or contacting the appropriate US Food and Drug Administration (FDA) review division for more information is possible. The table "Endpoints to be addressed in a biological risk assessment" was revised by the 2018 edition of ISO 10993-1.