A change like that shouldn't be a big deal. A meeting to decide whether or not it constitutes a Design Change (it doesn't!) and if the new insert needs to be Va

A change like that shouldn't be a big deal. A meeting to decide whether or not it constitutes a Design Change (it doesn't!) and if the new insert needs to be Validated again (likely not) and you're pretty much done from a Compliance standpoint and on to Vendor Qualification. My guess is that the problem is more likely to be finding a vendor that can print/cut to your specification at the scale you need and, critically, who can produce it on your schedule. Any capable printer is likely already booked solid for months.