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.
These controls are specifically intended to manage a medical device company's new product development activities.
This file shall also contain records for changes in design and development (per device type or family).
It might contain e.g. a design and development plan, or test reports; and is thus comparable to the DHF of the FDA regulations.