If the only thing changing on a device component drawing is the “critical” status of a specific feature, what would be the minimum evidence required to show its ok to remove? Risk assessment/review and evaluation of results from existing/periodic process validation activities? would there ever be an instance where validation activities would not need to be pointed to? How would you handle the potential case that reason for critical status is not explicitly called out in dfmea or pfmea, but possibly has an indirect impact on something else? Doing a regulatory assessment but just not sure we can say, yeah it’s ok to remove without pointing to actual evidence. thank you in advance!