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 OF THE PRODUCT DEVELOPMENT DOCUMENTATION PERTAINING TO A FINISHED MEDICAL DEVICE.

The creation of a DHF is the last step in the design controls process mandated by the FDA in 21 CFR Part 820. While the majority of the medical device compliance regulations enforce the establishment of policies and procedures for enforcing quality standards, the DHF is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development. Design controls are one of the core processes of the overall quality management system (QMS) mandate, and the presence, completeness, and accuracy of your DHF goes a long way towards helping you pass your next FDA audit.

WHAT ARE THE FDA GUIDELINES FOR DHF?

The design history file requirements live in 21 CFR Part 820.30, which contains the regulations for the design controls process. You'll have to refer to subsection j) for the specific text on DHF, but we managed to squeeze it in below:

"j) Design history file. 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."

Here are some key interpretations of the DHF guidance that medical device companies should take note of:

  • 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 of the data in a single DHF.
  • The DHF demonstrates that the device was developed in accordance with both the design plan and the requirements of this part. Your design plan must reflect compliance with the design controls process and should be included as part of the DHF. Your completed DHF reflects compliance with the design controls mandate and your design plan.
  • 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. In the latter case, the materials would be stored in a software QMS and the DHF would be used to access them.

WHAT BELONGS IN YOUR DHF?

Your DHF should contain all of the documentation created during the product development phase of your medical device. Following the mandated design controls process closely will help you understand what documents are required, as each step generates its own documentation. Below, we've listed the most important steps of the design controls process and what documents should be included with each step.

  • Design and development planning - include your design plan document, developed according to this part.
  • Design input - include procedures for establishing design input that addresses the intended use and user needs (learn about establishing user needs here), and the approved design input documentation itself.
  • Design output - include your procedure for defining and documenting design output in compliance with this part, and the approved design output documentation itself (learn more about design inputs and outputs here).
  • Design review - include your procedure for conducting reviews of your design process and any documentation related to the reviews that were conducted.
  • Design verification - include a document describing your design validation process and the approved results of the design validation
  • Design validation - include the specific procedure and testing conditions used for design validation, as well as the approved results of the design validation process (read more about design verification and validation here).
  • Design transfer - include the documented product specifications that are developed in compliance with this part and a description of the process used (also check out our guide to design transfer best practices).
  • Design changes - include the documented design change process and documentation pertaining to any design changes that have taken place.

GREENLIGHT QMS MAKES DHF THE EASIEST PART OF DESIGN CONTROLS

Greenlight QMS makes it easier than ever to compile your DHF just in time for an FDA or ISO audit. The DHF regulations allow medical device companies to present their DHF as a document that references the product development documentation for your medical device. Greenlight's QMS acts as a secure reference library that holds all of your product development documentation where you can quickly and easily link to it from your DHF. Instead of assembling, photocopying, and perpetually updating a physical file folder with hundreds of pages, medical device companies can produce and update one document for their DHF that references the documents in the QMS. With Greenlight QMS, creating and maintaining a DHF is so easy, it's practically done for you.

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