From my experience in working in the industry, the DHF i believe should be a living document along with the DMR. I can understand that the DHF is a history of the initial design history, SOP's, and design control documents such as DID, DSD and PDF along with the Validation and Verification protocols and reports. In the company that I work for currently, this document is a living one in the sense that the document can be edited and made changes with a Change Order Request; however ensuring that the changes does not change the general concept of the product, otherwise it would be considered a new product to the FDA. As mentioned prior by the previous students, the DHF is a snapshot of what the product stands currently. The DMR on the other hand is a record of all design drawings, processes, etc. This document will reference all the changes done in the DHF as well.
In my opinion DHF is a living document (as we have learned) and must updated regularly. Your DHF should be a collection of the objective evidence that demonstrates you’re following 820.30. and every document in the DHF must be updated as you go in your design. If you’re lined up for an inspection, you could get into trouble with FDA if it’s not updated. They expect all changes to be assessed from a design control perspective.
So, keep your DHF updated from the beginning of the project if you want a better chance of getting through your inspection unscathed!
The school of thought that says that the DHF is sealed at the end of Design Transfer is most appealing to me, and that is the school of thought that my company follows. We have quite a large product portfolio, so if we had to update every DHF every time we updated any SOP or our design control procedures, I think we would be spending almost all of our time updating old DHFs for products that are currently on the market rather than focusing our efforts on developing new products. As new procedures and updates to our design control procedures are rolled out, we implement them in new projects, but we do not go back to old DHFs to assess whether they comply with the new procedures.
We work with outside companies that design/develop our commercial medical devices. So I indirectly come into contact with DHFs, but don't have an influence on the practices of the company we contract to develop the device. I personally however think the school of thought that says the DHF is a living document is most appealing to me, because I think if changes are made (even if they are small) they should be captured in the DHF. I think having a central electronic document to go back and see the changes is essential and would be good in case the FDA came in for an audit because it would be an accurate representation of the product you are delivering to the consumer on the market.
Of the two processes involved in the logging of changes made to the DHF, the second one seems better. When changes are being made to the product, even after the Design transfer, there should be a copy in the DHF noting these changes. Any change made to the design is important, no matter how small it may seem. As a result, there should be a record of the changes. This way if something is misunderstood or incorrect in the design there will be a way to track it in the DHF. However, I do feel that if there is a complete difference in the product when there is a change in the design, there should be a new DHF issued. When there is a huge difference in the product then it becomes a different product, even if it is meant to improve the current idea. In a way a combination of the two ideas would be the most efficient.
It is most sensible for the DHF to be a living document, as updates are made and the design revised, it must be permanently logged. Even post design transfer, it is important to update the origin of these designs so that it is in a central location, instead of some being scattered in the DMR. While this school of thought is the most logical, it is not always followed this way, especially for very old devices that have been updated over a series of decades. For example, in our company there are many revisions to the SOP of device manufacturing, from small changes in the location of a gage to a whole process being reconfigured. This change is not added to the DHF but instead is appended to the DMR as there have been a vast number of revisions over an extended period of time. Ideally, if this was the practice from the beginning of the device life, keeping the DHF as a living document would be more feasible.
The DHF is a living document.
Logically to me it doesn't even make sense why it wouldn't be. What is the point of documenting just the original process if you are going to open a 2nd DHF if the product changes due to indications of use or design changes? The DHF should be the original changes plus the ongoing continuous changes of that product.
At the company I currently work at, we made a minor change to the material of the fabrication of the device and every step of the process was recorded and documented under the current DHF that the device was created under. I believe opening a second DHF, which may have a lot of the same information as the current DHF of the product, would be a waste of time and resources.
A design history file (DHF) is a compilation of documentation that describes the design history of a finished medical device. In my option, The DHF is a living document, which means as changes are made to the medical device, SOPs, labeling, or packaging to the device, etc, the DHF should also be updated and be as accurate as possible. DHF is sealed at the end of Design Transfer and never altered, which I think is not effective, because if a change is made to anything on the device a second DHF has to be opened with almost exactly the same information as the first DHF, instead of just adding the changes to the original DHF. I believe that all information having to do a specific medical device should be contained in ONE DHF file that is able to be updated as changes happen.
I understand the idea of using the DHF as a living document to detail design and development plans and deliverables. However, at my company, once the product has been transferred, the DHF is sealed and any changes must be implemented via design change activities according to FDA Design Control regulations. From my understanding of regulation, ongoing changes to Device specifications, composition, formulation, component specifications, software, and labeling and packaging specifications should be reflected in the DMR.
I agree with previous comments about the DHF being a living document. I would like to add on the previous ideas about the advantageous of it being a living document.
1. Being a living document, DHF will be updated after the development phase as well -> good for transparency, the DHF is the representation of the product you are delivering.
2. Easier to keep everything organized and up-to-date, this is very important for inspection and audits.
I agree with others that the Design History File (DHF) is a living document. The FDA states that " 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 (21 CFR Part 820.30). Each manufacturer shall establish and maintain a DHF for each type of device." To add to the conversation, as @thuytienlecao mentions its important to have the DHF as a living document because if the FDA audits you, you need to have a traceability matrix through the entire process from development to manufacturing. If the safety and efficacy and processes isn't transparent during the inspection, the FDA could do a 483 observation and require you to fix your DHF. That's why its important to keep DHF as a living document and update and keep it organized.
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