These are general rules for USFDA approval process. Mostly this relates to drugs and medicine. So I’m not so sure if it applies here.
From what I’ve heard in Concalls, it gets easier if it’s already UN-approved. Then it also needs a long period of testing and the results submitted to USFDA (Which Cupid did in Africa).
UNFPA pre-qualification process: Prequalification Programme for Female Condoms
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