In general I agree with Victor's conclusion - the surest way, by far, is to create separate documentation. However, I have seen another alternative work. This alternative is to create "tags" in your inputs and other documents that say "US only", "EU only" and "All". Then you can have one design input document, trace matrix etc that clearly "tags" which elements apply where.
Generally, when doing this, it is still better to have completely separate documents for certain key items. For instance, the risk/benefit analysis is nearly impossible to write clearly if you try and combine different indications. This also tend to be true for clinical evidence reports. You would want to sit down with the team and create a careful plan as to how this would be structured ahead of time, as having team members use differing approaches would likely cause problems as you near the end of the project.
This is certainly not the best approach, but it can work, and for smaller companies, can be a way to better manage resources. Just be sure whoever your front room audit/inspection leader understands the structure well and is comfortable explaining it!
g-
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Ginger Glaser RAC
Vice-President, Quality and Regulatory Affairs
Maplewood MN
United States
Original Message:
Sent: 03-Aug-2016 08:03
From: Victor Mencarelli
Subject: USA vs EU Product - Different Indications for Use
Hi Diana.
First, let me simply state that I can feel your pain with respect to having a stretched team. It seems in some situations that the RA function is inevitably understaffed and over-stretched. That said, I don't know if you are going to like the answer I come up with.
Unfortunately, the only way to truly insulate your firm from significant questions and having to defend the products on both sides of the Atlantic would be to essentially develop the documentation as if you were truly developing 2 separate products. That said, much of the same information may wind up in both document sets. But if you want to be able to insulate the claims between the US and EU you need to really look at the idea that if the document is in the file, the audit is likely to find it, ask about it, and even potentially write you up for it. Think of it this way - from an auditor's perspective, if the same information is used for 2 devices with 2 different indications for 2 different jurisdictions, it is far too easy to have a labeling mix-up which could misbrand the device.
I may be alone in my opinion here and look forward to other's comments, but this is one instance where extra work now may eliminate significant extra work later that could easily be seen to include the need to split the documentation up anyway.
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Victor Mencarelli
Sr. Manager - Regulatory Affairs
Hain Celestial Group
United States
Original Message:
Sent: 02-Aug-2016 10:24
From: Diana Korda Hewitt
Subject: USA vs EU Product - Different Indications for Use
Hi All,
I am currently working on a product that will have a different indications for use in the EU and the USA.
My challenge is currently how to manage my development documentation in such a way as to be able to demonstrate that the product is only indicated for the use in the USA without the EU indications been read as a USA one which could result in an adulterated product charge, or worse commercialising a device without authorisation. The risk is in the Establishment inspection later on in the future.
My thinking at present is to have the design brief very clearly highlight that there is a difference in the two indications. This means however that the design inputs and outputs might have to be different documents as I would effectively be looking at two different products. As you would appreciate it, this is something that I would rather avoid if possible as this would be extra work for an already stretched team.
Any debate on this is welcome.
Thanks for reading.
Diana
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Diana
Royston
United Kingdom
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