Me again!

Trying to find a solution to comply with both, ISO 13485 and 21 CFR 820, what about this structure:

DHF for Design Phase,
Technical Documentation Parts A and B; Part A = Technical File, Part B = DMR, for documentation of finished products.:D

I tried to combine information from NB-MED/2.5.1/Rec5 and several publications. What do you think? Remember: we are an European MD Manufacturer (Class III products).

And another one: Can anybody tell me the sense or profit of a STED (Summary Technical Documentation) from GHTF? I think it´s the same as my Technical File and so I don´t need ist additionally to DHF, DMR and Technical File.:confused:

Thank you for all responses and ideas!
Cosma

Hi cosma

I always thought the DMR was an output of the Design Phase, part of the design transfer, and not part of the DHF. Are you compiling purely from a regulatory side? as the DHF has (I thought) other documentation other than technical specifications!

If putting together for a 510k submission I believe this would be OK but from a regulations point you need to meet 21CFR Part 820.30 (Subpart C, Design Control) which require evidence (records) of things like planning, input, verification... etc

Maybe its just me but a little clarification about what you mean by DHF would help

cheers Nigel

And another one: Can anybody tell me the sense or profit of a STED (Summary Technical Documentation) from GHTF? I think it´s the same as my Technical File and so I don´t need ist additionally to DHF, DMR and Technical File.:confused:
Cosma

Had a quick look at STED on FDA website, its says it is a uniform approach for regulatory submissions, I would guess that it would be easier (a) to submit and (b) to review the submissions if they are all the same?? I have looked at a few 510(k)'s on the site and they do not appear to be all in the same format, it did say this was a pilot, and the links look like they point to draft documents. As reg submission is not my area I hope another Cover can answer this better

http://www.fda.gov/cdrh/ode/guidance/1347.html

The link lead to some details on STED and it appears not all devices are applicable

Hi Nigel,

I mean the DHF (Design History File) as described in 21 CFR 820.3. It "only" contains design phase and ends with design transfer. In 21 CFR 820.8 is written that finished design output is basis for DMR.
The DMR is not part of the DHF, they are two separate documents. But the DMR can be interpreted as part B of the technical documentation according to NB-MED/2.5.1/Rec5, I think.

My intention is not to create two separate documentations (one for FDA and one for our European Notified Body) but one documentation that covers all. I also don´t like documents to be only a "list of contents" because I can´t find any sense or profit in it. So that´s why I tried to do it the way I described in my first post.

Did it get a bit clearer now what I´m trying to do? I think it is very hard to comply with all the different reguations and even the recommendations and guidances are sometimes not a big help...:(

Greetings
Cosma

Hi Nigel,

I mean the DHF (Design History File) as described in 21 CFR 820.3. It "only" contains design phase and ends with design transfer. In 21 CFR 820.8 is written that finished design output is basis for DMR.
The DMR is not part of the DHF, they are two separate documents. But the DMR can be interpreted as part B of the technical documentation according to NB-MED/2.5.1/Rec5, I think.

My intention is not to create two separate documentations (one for FDA and one for our European Notified Body) but one documentation that covers all. I also don´t like documents to be only a "list of contents" because I can´t find any sense or profit in it. So that´s why I tried to do it the way I described in my first post.

Did it get a bit clearer now what I´m trying to do? I think it is very hard to comply with all the different reguations and even the recommendations and guidances are sometimes not a big help...:(

Greetings
Cosma

Hi Cosma

I think I understand now thx for the clarification...

Part A will be Technical File for PMA, 510(k) submissions and as such will give the intended use and the materials used when manufacturing the device.

Part B will be the specs, drawings, diagrams, procedures etc required to build the device

As required by NB-MED/2.5.1/Rec5, 3.4 Design (ii) and (iii) respectively

Part A would be a result of Design Verification/Validation and Part B would be the DMR.

In terms of submission for PMA for Class III (BTW do you require a Class III 510k?)

Below taken from FDA

A Premarket Approval (PMA) application is a scientific, regulatory documentation to FDA to demonstrate the safety and effectiveness of the class III device. There are administrative elements of a PMA application, but good science and scientific writing is a key to the approval of PMA application.

This I think would be your Part A from what you have said and looking at NB-MED/2.5.1/Rec5

If a PMA application lacks elements listed in the administrative checklist, FDA will refuse to file a PMA application

You would need to compare this checklist with the requirements for Europe, I would guess they are similar (note use of word guess :notme:)

Below is link that may help

http://www.fda.gov/cdrh/devadvice/pma/

My take would be if you can have 1 checklist that meets both and have your Part A mirror the checklist you develop. Then you will have all documents in file for submissions.

If not, then worst case you maybe have to do further testing to meet a requirement of one or other.

it will be two submissions, but if Part A have all the information required for both at least it would be in one place.

IMHO I think it would be worth having your Part A Technical File have all the info required for both and prob the easiest way to achieve this would be to have the information collated during V&V (Ensure that Development create the documents you require for submission) so you can submit for PMA, in other words make it mandatory in design phase to ensure this is done and give them a checklist of documents they must provide.

And looking at the DMR requiremnets I think that Part A + B would be your DMR if it includes the records, forms, Work Instructions, Procedures aswell, if not then this listing... sorry, would need to be held elsewhere.

The Regs do not require the DMR to be 1 file in one location it can be spread out as long as you can show control, so you can have several parts to make up the DMR and the listing above could come from your Doc Control Group, you need to have seperate DMR's for each product.

Sorry for the long reply... :rolleyes:

cheers have a good weekend

Hi,

thank you for your detailed answer! I think it is the way I´ll try to do it.
I found a picture that describes what I tried to do (see below). It tries to cover European Regs and refers to the equivalent FDA docs.

In this picture you can see that DMR is Part B of Technical Documentation. But there´s nothing written about Part A being used for 510k especially. (By the way, our 510k has already been made by our Reg Affairs Department so Part A doesn´t need to do it again, or not?) I thought it is for giving information to NB in case of an inspection, audits, etc.
I just won´t have the design dossier because I think it´s the same as the DHF. And I see Developmnet Documentation and DHF as the same document.:confused:

Please correct me if I´m totally wrong in my interpretation!

Greetings
Cosma

This is my first post. I am relying heavily on this thread for direction on how to satisfy both U.S. and E.U. documentation requirements. Can someone please provide some feedback on the picture that Cosma posted on March 4th? I thank every one of you who has contributed to this thread and my understanding of the overlapping documentation requirements of the two economic regions.

David S.

Dear Quality Gurus,

Having read and going through DMRs, DHF, Technical files and STED ( a new one for me) even though they all are simialr documents, I find that the format and the rules of STED are much more formalised and therefore I am confused. Would be appreciated if I could have some kind of example (template)for STED as per the official format ( Medical device Class II)(For your information: preparing technical documents for Japan's PMDA).

Looking forward to get some help.:)

My recommendation would be to abandon hope of finding a common-denominator format that will adequately focus on each different regulator's disparate requirements to an adequate degree, and instead just prepare the different documents you need.

By following this course, you can tailor each document for its recipient's expectations. In our experience, that's essential.

My recommendation would be to abandon hope of finding a common-denominator format that will adequately focus on each different regulator's disparate requirements to an adequate degree, and instead just prepare the different documents you need.

By following this course, you can tailor each document for its recipient's expectations. In our experience, that's essential.

Thank you for your response. Will follow your advice and prepare different Technical files as per different requirements. Sometime I sit and think--Why can't everyone agree on single global requirement...life would have been easier that way....afterall humans ( the ultimate customers) are the same everywhere......:confused: