Design History File (DHF) Maintenance Information wanted

sreenu927

Quite Involved in Discussions
#1
Hi my dear covers..
I seek your advise regarding the maintainance of DHF.
we have a project to launch one product in US, we got FDA clearance.
Now, we would like to expand the scope of the project to launch in EU..and would like to maintain the DHF..so now, some new tests are done for EU launch,hence extra docs came in..
so the question is, do we need to maintain a separate DHF with separate part number, in which some docs will be upgraded with revisions, a few will be overlapped.

Or, same DHF with revision upgrade?

In this case, if FDA comes to audit (may be over a period of time(, then some addition docs are appended in DHF which are not required for QSR, wil it be a problem?

Waiting to get your thoughts.

Thanks,
Sreenu
 
Last edited by a moderator:
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U

Umang Vidyarthi

#2
Re: DHF maintenance

Hi my dear covers..
I seek ur advise regarding the maintainance of DHF.
we have a project to launch one product in US, we got FDA clearance.
Now, we wud like to expand the scope of the project to launch in EU..and wud like to maintain the DHF..so now, some new tests are done for EU launch,hence extra docs came in..
so the question is, do we need to maintain a separate DHF with separate part number, in which some docs will be upgraded wid revisions, afew wil be overlapped.

Or, same DHF with revision upgrade?

In this case, if FDA comes to audit (may be over a period of time(, then some addition docs are appended in DHF which are not required for QSR, wil it be a problem?

Waiting to get ur thoughts.

Thanks,
Sreenu
Hello Sreenu,

DHF is an abreviation of many things from engineering to medical to Dag Hammarskjold Foundation. Since you have mentioned about FDA (Food and Drug Administration) then engg. is out. You will be able to fetch better responses if you be clearer on your querry.

Umang :D
 

bio_subbu

Super Moderator
#4
Re: DHF maintenance

Hello Sreenu,

DHF is an abreviation of many things from engineering to medical to Dag Hammarskjold Foundation. Since you have mentioned about FDA (Food and Drug Administration) then engg. is out. You will be able to fetch better responses if you be clearer on your querry.

Umang :D
Hi Umang

Sreenu is looking for the information on Device History file (DHF), Design History File is a compilation of documentation that describes the design history of a finished medical device. For more information refer here

Sreenu

Can you please request moderators to move your thread to Medical Devices (21 CFR part 820) section

Regards
S.Subramaniam
 
Last edited:
M

MIREGMGR

#5
Re: DHF maintenance

In a multiple-regulatory-system-compliance context, I don't think the FDA is going to have a problem with the DHF containing information that is required per MDD compliance, but not directly related to 21CFR820 compliance.

In any case, an FDA inspector will request to see specific categories of information for a product, expecting that information to come from the DHF. They are unlikely to want to review the whole DHF as an object in itself.

The device company for which I work has thousands of products, some of which have thirty year design histories. We maintain a single system of design history records, which meets our regulatory compliance requirements in regard to FDA 21CFR820, HC and EC MDD. We've had no negative feedback from anyone.
 

Ajit Basrur

Staff member
Admin
#6
Re: DHF Maintenance Information wanted

Hi my dear covers..
I seek ur advise regarding the maintainance of DHF.
we have a project to launch one product in US, we got FDA clearance.
Now, we wud like to expand the scope of the project to launch in EU..and wud like to maintain the DHF..so now, some new tests are done for EU launch,hence extra docs came in..
so the question is, do we need to maintain a separate DHF with separate part number, in which some docs will be upgraded wid revisions, afew wil be overlapped.

Or, same DHF with revision upgrade?

In this case, if FDA comes to audit (may be over a period of time(, then some addition docs are appended in DHF which are not required for QSR, wil it be a problem?

Waiting to get ur thoughts.

Thanks,
Sreenu
Sreenu927,

If you refer the Design Control Guidanceon the FDA website, it clearly states -

Section J - Other national regulations require some form of documentation and records. Product documentation required by Canada, Europe, and Japan contain certain elements of the U. S. FDA design history file requirements without requiring all the elements to be compiled in a file.

Additionally, DHF is now a globalized document and need not be duplicated for Europe seperately. The document also states -

FDA wishes to acknowledge the contributions of the Global Harmonization Task Force (GHTF) Study Group 3 to the development of this guidance. As has been stated in the past, FDA is firmly committed to the international harmonization of standards and regulations governing medical devices. The GHTF was formed in 1992 to further this effort. The GHTF includes representatives of the Canadian Ministry of Health and Welfare; the Japanese Ministry of Health and Welfare; FDA; industry members from the European Union, Australia, Canada, Japan, and the United States; and a few delegates
from observing countries.

Hope that clarifies :)
 

sreenu927

Quite Involved in Discussions
#7
Re: DHF Maintenance Information wanted

Hi Subbu, MIREGMGR and Ajith,

Thank you very much for ur suggestions.
I'l go thru it and workout to have a single DHF.
Wil let u know soon.

Regards
Sreenu
 
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