I have some insight into the FDA's submission system.
There are some inconsistencies in what the commenter here is claiming, and the experience of my company submitting software to the FDA for approval. I would not call their new system streamlined, and as I have been told from time to time that their database is down I am curious how it could be using XML on the backend. Is XML over HTTP part of their patent? If the patent is for XML in Word, well, Word is not even in that web-based workflow. Further, and this is just a nit-pick I realize that the guy may have misspoken. That said, assuming there is XML on the backend, and it is using an "open standard chiefly developed from . . ." i4i's tech, then it is not really an open standard is it?
In short, based on my knowledge, derived from extensive involvement in regulatory affairs in the medical imaging field, the second paragraph in that comment is highly suspect.
There are some inconsistencies in what the commenter here is claiming, and the experience of my company submitting software to the FDA for approval. I would not call their new system streamlined, and as I have been told from time to time that their database is down I am curious how it could be using XML on the backend. Is XML over HTTP part of their patent? If the patent is for XML in Word, well, Word is not even in that web-based workflow. Further, and this is just a nit-pick I realize that the guy may have misspoken. That said, assuming there is XML on the backend, and it is using an "open standard chiefly developed from . . ." i4i's tech, then it is not really an open standard is it?
In short, based on my knowledge, derived from extensive involvement in regulatory affairs in the medical imaging field, the second paragraph in that comment is highly suspect.