Hi

I'm just wondering if anyone can help me on the document pagination problem I have now and if the FDA is strict with this issue?

We are a new manufacturing medical device company and our product hasn't launched yet and we're still waiting for the FDA approval to market the product. Since we are still new, we have a subcontractor who manufactures our prototype products and release documents like BOMs, schematic, assembly drawing, assembly instructions, product requirements, marketing requirements and so forth. They released the documents without the coversheet, and starts with page 1 of the total no. of pages. In our end, we also release their documents (since this is pertaining to our product only or should I call it our proprietary document) with our own coversheet. But then the pagination is now affected. The page 1 of the released document of our subcontractor is now our page 2 and the rest of the pages are now affected too. Some of their released are already in pdf or scanned so we can't change them. And therefore the pagination is somewhat confusing now. One of our documents starts with page 1 of 30 (that's our coversheet) and then the second page which is the actual document from our subcontractor has page 1of 29, so there are two "page 1."

I resolved the problem by not putting any "page 1 of x" on our coversheet, but then I'm not sure if this style is acceptable to FDA. If the document is in MS Word file, I just attached our coversheet and will automatically renumber the page numbers of the whole document. But for BOMs, schematics, assembly drawings which are in pdf files I can't renumber them.

Does it matter a lot the pagination of documents or drawings with the FDA?

Can someone share thoughts on this issue.

thanks

Hi

I'm just wondering if anyone can help me on the document pagination problem I have now and if the FDA is strict with this issue?

We are a new manufacturing medical device company and our product hasn't launched yet and we're still waiting for the FDA approval to market the product. Since we are still new, we have a subcontractor who manufactures our prototype products and release documents like BOMs, schematic, assembly drawing, assembly instructions, product requirements, marketing requirements and so forth. They released the documents without the coversheet, and starts with page 1 of the total no. of pages. In our end, we also release their documents (since this is pertaining to our product only or should I call it our proprietary document) with our own coversheet. But then the pagination is now affected. The page 1 of the released document of our subcontractor is now our page 2 and the rest of the pages are now affected too. Some of their released are already in pdf or scanned so we can't change them. And therefore the pagination is somewhat confusing now. One of our documents starts with page 1 of 30 (that's our coversheet) and then the second page which is the actual document from our subcontractor has page 1of 29, so there are two "page 1."

I resolved the problem by not putting any "page 1 of x" on our coversheet, but then I'm not sure if this style is acceptable to FDA. If the document is in MS Word file, I just attached our coversheet and will automatically renumber the page numbers of the whole document. But for BOMs, schematics, assembly drawings which are in pdf files I can't renumber them.

Does it matter a lot the pagination of documents or drawings with the FDA?

Can someone share thoughts on this issue.

thanks:2cents:Personally, I would have done it differently. But, since this is the way you have chosen, as long as you explain your documentation structure within your system you should not have a problem (ref: 21cfr820.20(e) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.20)).

:2cents:Personally, I would have done it differently. But, since this is the way you have chosen, as long as you explain your documentation structure within your system you should not have a problem (ref: 21cfr820.20(e) (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.20)).

Can you share with me what's your idea? How would you deal about this issue?

thanks

Can you share with me what's your idea? How would you deal about this issue?

thanksYour document could be one page just specifying their document including the rev level. If they roll the rev, you can follow suit.