PMA (Parts Manufacturing Approval) Supplement - Labeling Software Change

R

regcomp

#1
Hello everyone,

I am working on a project and need some guidance. Would I have to submit a PMA supplement for a Class 3 product if am changing the labeling software(software used to create-store-print labels). Any guidance is appreciated.

Thank you.
 
Elsmar Forum Sponsor
M

MIREGMGR

#3
Was the prior software (plus your network etc.) validated to meet a comprehensive spec, and has the new software been validated to meet the same spec?
 
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