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A Design History File, DHF, is part of the requirements set by the FDA and other regulatory bodies for the development of medical devices. This is a file that essentially details the entire development of a medical device, from the planning stage on, and contains all documents related to that development. DHFs are part of the Design Controls requirements of the FDA which is part of 21 CFR part 820.[1] The FDA provides guidance on Design Controls and outlines what a DHF needs in the CFR.

In general, a DHF is comprised of a few major sections. These sections include, but are not limited to, planning, design inputs, design outputs, design validation, and design verification. There are several other sections that are usually included in a DHF, that being said the FDA does not explicitly state how exactly a DHF needs to be structured, just that it must contain the necessary information to show the device was developed in accordance with regulations. So, it is up to the manufacturer to decide on the overall structure of the DHF, it could even have no structure if they wanted, though that is not recommended. The DHF is meant to be a place to easily locate files related to a device so having a structure to it is important in that regard. Since development is generally broken up into various stages a DHF is broken up into sections mirroring those stages which allow for easier access to locating files from each stage.

The DHF needs to prove to any inspector that the device was developed properly. That being said, it should also not be over cluttered with unnecessary documents. For example, in the Design Verification section of a DHF, it is important to include all documents that prove that the design outputs have matched what is expected from the inputs. This would include documents that have testing data or filled-out templates of some kind. What would not need to be included in the Design Verification section is the unfilled templates. Those would be more appropriately placed in a different section, such as planning. Including the blank template in the Design Verification section may cause confusion and including it in multiple sections is unnecessarily repetitive.

 When being audited a DHF is where an inspector will look. Having a DHF that is clean and organized is important for passing that audit. EMMA International can help with the development of a DHF. EMMA International can help with the entire design and development process for a new device ensuring compliance with FDA regulations and any other relevant regulations every step of the way. Give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.


[1] FDA (September 2018) Design Control Guidance for Medical Device Manufacturers, Retrieved 12/05/2021 from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers

Gabe Kadoo

Gabe Kadoo

Mr. Kadoo is a Quality Engineer at EMMA International. He has experience in statistical analysis, performance improvement, quality assurance, and value stream mapping in the clinical setting. Mr. Kadoo also has experience as a clinical researcher and medical technologist. Mr. Kadoo holds a Bachelor of Science in Biology and a Master of Public Administration with a concentration in Healthcare Administration. He is also a Six Sigma Green Belt.

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