A Design History File or DHF is a documentation describing design history of a finished medical device. The DHF is an intrinsic part of 1990 regulation when the Safe Medical Devices Act was passed by the US Congress. The regulation sets up new medical device standards that may contribute to serious illness, death or injury of a patient. Before this regulation was passed, the FDA auditors were restricted to reviewing production and quality control of medical device records.
The DHF must explain the complete history of the design of a specific medical device or component assembly of a device. It must entail development of device, major components, packaging, accessories, labeling a well as the manufacturing process. The whole design history of the medical device must be clear when looking at the DHF. The file should also capture consistency and adherence of the design to regulatory and design control requirements.