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


What should a design history file contain?

The DHF should include design plans, drawings, design inputs and outputs, design review documentation, engineering change orders, and production transfer documents.

How do you create a design history file?

To create a DHF, compile the design control documentation in the following order:

  1. Design and development plan
  2. Design inputs
  3. Design outputs
  4. Design review
  5. Design verification
  6. Design validation
  7. Design transfer
  8. Engineering change orders

Using an electronic system to create, track, and update the documentation will ensure that the DHF is always audit-ready.

What is the difference between design history file and device master record?

The design history file is dedicated to documenting the device’s design history and ensuring that it was developed in accordance with the approved design plan. The device master record is concerned with the finished product and ensuring that all necessary items (i.e., components, packaging, labeling, maintenance procedures, etc.) are included.

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