Are there any guidelines for writing an Intended Use statement?

[mitsu11]

I know this is a seemingly simple question, but are there any guidelines for writing an intended use statement? I found the FDA guidance for General and Specific Intended Uses, but I still need help. The intended use statements that we have on our existing products are very long (2 paragraphs) compared to other examples I have seen. (Consultants created our existing statements, but I have found other areas where their work wasn't on taget, so I have reason to doubt them on this one.) By the way, our products do NOT have involved specific uses that might account for the length of the statements.

Maybe I am thinking too hard about this. I just feel that since this is a very important, publicly used (in some cases) statement, it needs to be crafted carefully. For instance, the products we have now might paint us into a corner as far as requiring future 510(k)s because of so much excess verbiage. I want to make my job easier, not harder.

[Al Rosen]

Originally Posted by mitsu11

I know this is a seemingly simple question, but are there any guidelines for writing an intended use statement? I found the FDA guidance for General and Specific Intended Uses, but I still need help. The intended use statements that we have on our existing products are very long (2 paragraphs) compared to other examples I have seen. (Consultants created our existing statements, but I have found other areas where their work wasn't on taget, so I have reason to doubt them on this one.) By the way, our products do NOT have involved specific uses that might account for the length of the statements.

Maybe I am thinking too hard about this. I just feel that since this is a very important, publicly used (in some cases) statement, it needs to be crafted carefully. For instance, the products we have now might paint us into a corner as far as requiring future 510(k)s because of so much excess verbiage. I want to make my job easier, not harder.

I don't believe there are any "guidelines". If you haven't done so, search the FDA 510(k) database for products with the same product code as yours and look at their statements.