What is a Design History File (DHF)?

Design History File Definition

A design history file (DHF) is a collection of records that describe the design history of a finished medical device. The DHF may include records such as design inputs and outputs, engineering change orders, and design review documentation. The FDA specifies requirements for the DHF in Title 21 CFR section 820.30 as follows: Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

What is a Design History File
Design History File (DHF)