And per 21CFR (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR..

And per 21CFR (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFR...), if you design part of a Medical Device on one, it must be signed and dated and recorded as part of the Design History File since it's now an Original Record :-)