"DHF" redirects here. For other uses, see DHF (disambiguation).
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.[1][page needed] Prior to this legislation, U.S. Food and Drug Administration (FDA) auditors were limited to examining the production and quality control records of the device.[citation needed]
^Harnack, Gordon (1999). Mastering and Managing the FDA Maze: Medical Device Overview. American Society for Quality. ISBN 9780873894555. Retrieved January 13, 2017.[page needed]
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was designed by the Internet Engineering Task Force (IETF) as an extension of the Secure Shell protocol (SSH) version 2.0 to provide secure file transfer...
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