Why Do You Need a Design History File?
In short, the FDA requires a Design History File (DHF) as part of the application and marketing process for medical device manufacturers. First required by the United States FDA in 1990 as part of the Safe Medical Devices Act, the DHF contains all the product development documentation pertaining to a finished medical device. Most importantly, the DHF is the culmination of the design and development activities of your medical device or in vitro diagnostic device.
The Importance of the Design History File (DHF)
Above all, medical device compliance regulations enforce the establishment of policies and procedures to ensure manufacturers maintain quality standards. Quality standards include the detailed record-keeping that support a DHF. However, the DHF may be best understood as an organizational tool. In other words, it’s a tool that helps demonstrate to the FDA that a design controls process was properly followed throughout product development.
Design Controls Explained
Most importantly, design controls are one of the core processes of the overall quality management system (QMS) regulation. In addition, the presence, completeness, and accuracy of your DHF goes a long way towards getting your product cleared-assuring you pass your next FDA audit.
What is within a Design History File (DHF)?
The DHF contains all the documentation created during the product development phase of your medical device, as well as a few records during the lifetime of your device’s manufacturing. Below are some of the most important documents the DHF should contain.
Design and Development plan
The design and development plan, of course, includes your design plan documentation.
Most importantly, the design review includes your procedure for conducting reviews of your design process. In addition, the review contains all documentation related to the reviews conducted.
Design Input Documentation
Input documentation maintains the integrity of the device. Therefore, the input contains the documents associated with the original use in design and regulation. In short, design inputs include industry standards, regulations, previous product features, competitor product features, or prototype evaluation results.
Firstly, output forms the manufacturing instructions for your device including drawings, detailed specifications, and manufacturing processes and procedures. In addition, design outputs describe all the components, parts, and pieces that go into your medical device. Finally, these outputs go “all the way down” to include all the assemblies and subassemblies of your product.
Throughout the design and manufacturing of a medical device, you need verification steps that ensures each design input requirement matches a design output. Therefore, you should include a document describing your design verification process and the approved results.
The specific procedure and testing conditions used for design validation, as well as the approved results of the design validation process, needs to be included as well.
Specifically, the design transfer is your plan to mass manufacture your medical device. Firstly, the plan includes the documented product specifications developed in compliance with each component. Also included, a description of the process used to manufacture each process all the way through to assembly and packaging of the final product.
Above all, nothing escapes change. As such, every firm must keep the DHF updated for each change made including the evidence and associated testing that each change has been made properly, and the effects of each change on the overall DHF for the device needs to also be included.
In short, the DHF includes a multitude of files that document the design and manufacturing process of your unique medical device throughout its life. Most importantly, the DHF is required to get your medical device safely and effectively to market.
Need help with your Design History File and FDA application? Let MAE Group’s Quality Management experts help. Contact MAE Group today.