Regulatory Open Forum

I am wondering what the typical path is to extend shelf life?  We filed our 510(k) with 1 year stability testing so were cleared for that but noted that we are targeting 2 years. We have just completed 2 years and I am wondering how to inform the FDA.  Is it usually a Note to File?  We will be filing an additional label expansion 510(k) but I am wondering if we could get approval for increase shelf life without waiting for this 510(k). 

In general, no new 510(k) is needed for a shelf-life extension if the extension is done using the same basic protocol that was used in the 510(k). But if a different protocol or method is used, then a new 510(k) would generally be needed.

I am wondering what the typical path is to extend shelf life?  We filed our 510(k) with 1 year stability testing so were cleared for that but noted that we are targeting 2 years. We have just completed 2 years and I am wondering how to inform the FDA.  Is it usually a Note to File?  We will be filing an additional label expansion 510(k) but I am wondering if we could get approval for increase shelf life without waiting for this 510(k). 

I am wondering what the typical path is to extend shelf life?  We filed our 510(k) with 1 year stability testing so were cleared for that but noted that we are targeting 2 years. We have just completed 2 years and I am wondering how to inform the FDA.  Is it usually a Note to File?  We will be filing an additional label expansion 510(k) but I am wondering if we could get approval for increase shelf life without waiting for this 510(k).