M
Worst case is that the pouch doesn't provide a benefit
Outreach and inservices are nice. Who will work with the users who don't receive the outreach and aren't at the inservice?
If I were reviewing, I'd say no.
Furthermore...you've identified a product shortcoming, and you're receiving a complaint stream regarding that issue. Are Medwatchs being filed by end users, and are you at risk of FDA concluding that there's an effectiveness issue? My view would be that if you're going to do something about that issue, that something assuredly should fix it. Your argument as presented here doesn't seem to me as if it would be convincing to an FDA inspector.
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