The creation of a Design History File (DHF) Per 21 CFR 820.30

Introduction

The Design History File (DHF) is a compilation of records that describes the design history of a finished device. 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.

The creation of a DHF is the last step in the design control process mandated by the U.S. Food and Drug Administration (FDA) in 21 CFR Part 820.30. The DHF shall be established and maintained for each medical device type or family.

 The Safe Medical Device Act of 1990 authorized the FDA to add Design Controls to the current Good Manufacturing Practice (cGMP) requirements for medical devices. This Quality System (QS) Regulation became effective on June 1, 1997, and replaced the 1978 GMP for medical devices. This preamble to the QS Regulation is extremely important for understanding the intent of Design Controls.

Key Elements / Steps in Device Design Control:

A DHF should contain all of the documentation created during the product development phase of a medical device. Following the mandated design controls process closely will help to understand what documents are required, as each step generates its own documentation. Below, we've listed the key elements and steps of the design control process per 21 CFR Part 820.30:

• Design and Development Planning:

Design and Development Planning shall establish, maintain, and document which describes or reference design and development activities. Also identify, describe, and define interfaces, responsibilities, and functions/activities which impact the device design.

• Design input:

Design inputs are the physical and performance characteristics of a device that are used as a basis for device design. Establishes and maintains procedures for Design Input which ensures requirements are appropriate by addressing user needs and intended use(s) in terms that are measurable by addressing ambiguous or conflicting requirements.

• Design Output:

Design outputs are the results of a design effort at each design phase and at the end of the total design effort. Prepare procedures for Design Output which define and document design output in terms that allow an adequate evaluation of conformance to design input.

• Design Review:

Design review is a documented, comprehensive and systematic approach to review design at appropriate stages and evaluate the adequacy of the design requirements and capability of the design to meet requirements.

• Design Verification:

Design verification is confirmation by objective evidence that design output meets design input. Establish and maintain procedures for design verification to confirm through measurable means (e.g., test reports, etc.).

• Design Validation:

Design validation means establishing by objective evidence that specifications (specified requirements) conform with user needs and intended use(s). Establish and maintain procedures for design validation: 

• Under defined operating conditions;
• On initial production units, lots, or batches (or their equivalents); and
• Under actual or simulated use conditions.

• Design Transfer:

Establish and maintain procedures to ensure correct Design Transfer into production specifications.

• Design Changes:

Establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation.

Conclusion

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.

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