Design history file

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. 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.

The regulation requires medical device manufacturers of Class II and Class III devices to implement design controls. These design controls consist of a development and control plan used to manage the development of a new product, and a design history file where these activities are documented. These controls are specifically intended to manage a medical device company's new product development activities. Research and development processes aimed at developing new underlying technologies are not subject to these regulations. The requirements for a DHF are documented in FDA Regulation CFR 21 820.

Each manufacturer of either a class II or class III medical device (as well as a select group of class I devices) needs to establish and document procedures on the design and design requirements. These design controls include:

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