According to the FDA, “the design history file 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 (21 CFR Part 820.30). Each manufacturer shall establish and maintain a DHF for each type of device.”
I came across this interesting article on “How to Prepare Your Design History File for an FDA Inspection”. Main points on common mistakes to avoid include:
1. “The Unruly File”
Having a disorganized file folder will mean the company will trouble finding the pertinent information, which may lead the FDA to believe that something else could be missing. So make sure the DHF is organized.
2. “Paper Problems”
The most common format for a DHF is still paper and having multiple papers, you may lose one along the way and sometimes signatures or sections can be left incomplete so the article stresses the importance that DHF should always be accurate and updated.
3. “The Overcompensating DHF”
As the article states, another common mistake are that the company will add everything they possibly can to the DHF including business-related items which do not relate to safety or efficacy. It goes on to say that a DHF should fit with a project file and focus on design control activities that demonstrate you’re following 820.30.
4. “No Traceability Matrices”
One of the key components of the design controls are the traceability matrices, which represent and lay out a roadmap of what’s in your DHF and shows the relationship from design control activities and can act as an important tool to keep team members on the same page. The FDA inspector will appreciate if you have a traceability matrice and can understand how everything works/is related.
5. “Constructing A Traceability Matrix Late in Development”
As the article mentions it’s important to create a traceability matrix at the beginning of a project to create transparency among the company on what needs to be done.
Overall the article states the importance of organization and keeping accurate records and treating the DHF as a “living” document.