Design History File (DHF) is a compilation of records that describes the design history of a finished device. The Design History File (DHF) was first mandated by the United States FDA in 1990 as part of the safe medical devices act; it contains all the product development documentation pertaining to a finished medical device. It is necessary to focus on two aspects of the definition. They are:

  1. Defining which records comprise the DHF
  2. Focus on the Start and End Points of DHF

Defining which records comprise the DHF

Recommended procedures of a DHF: Although there isn’t an established template to prepare a DHF, the following are the usual contents of a DHF. The list below is what the FDA inspector will be looking for:

  1. Design Plan
  2. User Needs
  3. Design Inputs
  4. Design Outputs
  5. Risk Analysis, Including Hazard Identification
  6. Human Factors Analysis
  7. Design Verification, With Acceptance Criteria
  8. Design Validation, With Acceptance Criteria
  9. Design Changes
  10. Software Validation—If Applicable
  11. Design Reviews
  12. Design Transfer

The best practice for ensuring that these documents are created is to document each design review. A different form can be created for each phase of the design or a generic review form can be used for all the phases. Regardless of the choice of approach, the approach should be clear about which of the above documents are required as an output at each design review. It is also recommended to define who are the required attendees and approvers of the design review. There may be several optional people in attendance at the design review, but the minimum requirements for attendance should be 18 months. During the 18 months, design project titles and names can change.

Focus on The Start and End Points of DHF

The second aspect of DHF documentation is to focus on when the DHF begins and ends. If a DHF is initiated later in the design process, then the procedure specifies that summarization of some of the design activities had already taken place retroactively. Best practices for “closure” of a DHF is to close it when 510(k) clearance letter or PMA (Pre-market Approval) is received from the FDA.

Key interpretations of the DHF guidance are

  • A DHF must be maintained for each type of device that you manufacture. If you make similar versions of the same device and the designs are the same, you can include all the data in a single DHF.
  • The DHF demonstrates that the device was developed in accordance with both the design plan and the requirements. Your design plan must reflect compliance and should be included as part of the DHF. The DHF must either contain or reference the necessary documents. This means that you could either create a folder that contains the required documents or create a document that acts as a reference sheet for the required materials.

The above mentioned are general requirements for a DHF. It may vary from case-to-case. What’s your requirement related to DHF? Let us know. We can answer your queries and address any concerns you may have. Contact our experts at