Incomplete DHF: Re-do or plug gaps?

D

dave-o

#1
Hi all. I'm part of an organization which acquired another medical device company, and I've inherited a woefully lacking design history file for one product. It's missing far more than we are going to be able to fill in adequately. I'd like to create a brand new DHF for this product, and I'm curious as to whether or not there is anything to look out for when doing so, considering the product is out in the market, and is currently being marketed (it does have 510(k) clearance, despite the DHF gaps).

If I begin to create a DHF from scratch according to our company's design control procedures, creating new documentation (obviously dated currently), how do I cover old product? I'm assuming this is done through documentation/memos, etc, but can anyone give me an example of what that would look like?

Thanks! Long time lurker, I've gained a lot of insight from browsing over the last few years.
 
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M

maaquilino

#3
Hi all. I'm part of an organization which acquired another medical device company, and I've inherited a woefully lacking design history file for one product. It's missing far more than we are going to be able to fill in adequately. I'd like to create a brand new DHF for this product, and I'm curious as to whether or not there is anything to look out for when doing so, considering the product is out in the market, and is currently being marketed (it does have 510(k) clearance, despite the DHF gaps).

If I begin to create a DHF from scratch according to our company's design control procedures, creating new documentation (obviously dated currently), how do I cover old product? I'm assuming this is done through documentation/memos, etc, but can anyone give me an example of what that would look like?

Thanks! Long time lurker, I've gained a lot of insight from browsing over the last few years.
Some questions for you: How long has the product been on the market? Has this product ever been audited by the FDA? Do your procedures document how to handle this? From your question I?m figuring not, but they should be updated to cover this type of situation because you may run into it again on another product this other company put out, or it may happen in the future on a new product (I know, hard to believe; but some people don?t follow documented procedures :D)

If you create a new DHF completely from scratch according to your companies procedures, treating it as though you're designing the system now and following your SDLC procedures, have you investigated if/how that may affect your 501k clearance? Even if it doesn't affect it, I don't believe this is the best way to go.

As the current product on the market still has a current (lacking) DHF, and that DHF would be audited to the procedures in place at the time it was created, and because all documentation must be retained for the life of the product, imo it would be better to use what documentation you have and create/add what you need. And filling those gaps can be done based on your current procedures for design control.

I've been in this situation a number of times, and how we handled it was to simply create/modify whatever documentation we needed to bring the current DHF up to par and did a retrospective validation on the product based on that new documentation. In some cases that meant creating an entire SRS because there wasn't one. In other cases it meant revising ? based on our new design control procedures ? the current SRS which didn?t contain a lot of information and re-approving it. The same was done with the design documentation and any other documentation that was missing or lacking. In the project management plan it was noted why this was being done (lack of complete DHF, missing documentation, etc.) and how this was going to be handled. A retrospective validation was always done based on the new documentation.

Hope this helps!
 
M

MIREGMGR

#4
You certainly may add documentation to the DHF to provide retrospective clarity where the existing DHF is incomplete, and to improve its completeness on a forward going basis.

My view however is that, given that already-marketed product is related to the existing DHF, you may not discard or replace existing records. A newly created record, well after the fact of the events it documents, cannot be equal to an event-contemporaneous record as a mechanism for demonstrating compliance with 21CFR 820.30 and 820.40 requirements.

If US FDA regulation is applicable to the devices in question, you might want to review this situation with DSMICA before taking any actions that would have the effect of destroying old records and creating new ones.
 
D

dave-o

#5
Thanks for the input! To answer your questions:

This product has been on the market since 2007. It has been audited, and didn't do well. And no, our current procedures do not cover how to deal with missing documentation - I guess that's something we can jump on. There are very scant records of the design process, but it did go through thorough testing by a third party (electrical tolerances, EMF, etc). However, the DHF as it stands does not even contain specifications or, by extension, any verification or validation documentation. Over the last few months we've been bolstering it with what we can find and/or re-create, but some things just can't be created after the fact. Hence my desire to start all over with a nice fresh DHF :) I didn't think that was the best idea, but was hoping that maybe my gut feeling on that was incorrect.

Well, we'll keep trucking along on this one, patching where we can and explaining where we can't. Any thoughts on what the documentation should look like that explains why certain docs are missing? Is that a memo?
 
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