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DHF (Design History File) for a Legacy Product (Class iii Medical Device)

A

anoopmp

#1
Hi, :bigwave:

I am trying to establish a DHF for a legacy class-III product, which is in EU market from 1973. Most of the DMR data is available, but the design history data is missing. There is no design changes which are done on the product from last 3 years atleast. What would be the best option to establish a DHF.

:thanx:
Anoop
 
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M

MIREGMGR

#2
Re: DHF for a legacy product

I assume that the device is US FDA Class III. If so, its design state as of its PMA clearance was well documented. You could assign whatever persons...likely engineers, and perhaps others...have the best knowledge of what occurred to the design and when, from the PMA date to now, to write the best possible narrative of the design history. You may be able to document design changes by means of other dated records such as ECOs, bills of material, drawings, manufacturing work instructions and other similar records.

Obviously that's a less than ideal approach, and FDA might not like it at all in regard to your 21CFR 820.30 obligations if the finished record still has gaps or is undated, but I don't see how you practically could do more than that.

You'll want to document how you've made the best possible effort to recover from your documentation/records problem.
 
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TWA - not the airline

Trusted Information Resource
#3
I agree with MIREGMGR that you should start with investigating the design history as far as possible and document everything that up to now had not been put down in writing. The next step in my opinion would be to retrospectively establish a DHF for the product. For this you take your design control procedure and completely follow all its current requirements regarding documentation, reviews and approvals etc. and establish all the necessary documents for design input, design output, verification and validation activities etc. When filling in the information in the new DHF you start with what you found in your investigation and then explain the changes and fill out the remaining gaps.
 
A

anoopmp

#4
First Thanks to you MIREGMGR & TWA.

Looks like I am in the right path then.
So here is the flow. Correct me if wrong.

1. Get all documents available.
2. Perform Gap analysis.
3. Identify what data needed for fixing gaps.
4. Collect information as much as available to fill the gaps
5. Create design doc as per "Current" procedures and templates.
6. Perform reviews and approvals.
7. Note changes happened in the design (atleast for last 2 years)
8. Documents changes as per procedures and version control
9. Perform reviews and approvals.
 

TWA - not the airline

Trusted Information Resource
#5
Looks good to me. Some details to keep an eye on:
- Put the flow down in writing and call it a plan.
- Put down a rationale/memo to file for all things from your design control procedure that are not applicable for retrospective DHFs for legacy products (maybe also as part of your plan).
- Do not forget to document the review and approval of things that are fine and do not need amendmends (typically in the DMR, as the product is already being manufactured for a long time).
 
F

Fa Pa

#6
Glad I found this forum!!!

We a very similar issue. Some of our product is missing significant portions of the DHF. Items, such as Design Input/Output Traceability Matrix (which should contain dates, or a gantt chart and resources, etc). I can investigate, interview engineers involved in the design in that project but what do I do with items that require dates and signatures from people no longer in the company?
Same thing with the V&V records. Can I do a retrospective V&V plan? How would I handle the test reports? Only good thing is that we do have some of the validation records around.

Please help!
 
O

Oscar Wang

#7
Hi:
i think there are two scenario. Senario I is that the old MD has already got a 510(K) and marketed in US. in this case, i think your remedial plan is feasible and suitable solution. i need to emphasis that if old verificaiton result needs to be cited, you should be very careful to determine that whether this test result is still available for current device. In Scenario II if this device is newly application for 510(K), i suggest that you redo the development process and generates a complete new set of DHF. this will help you with following activities such as design change and so on.
 
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