u/-watermelauren

We submitted, we received deficiencies, and now the VP of our business is hung up on throwing the least burdensome flag. I’ve never done it, I’ve never heard of anyone doing it, let alone having success, and most importantly, I have serious doubts if there is any value. We are already strapped for time - why would we dick around with challenging FDA, winding them up, waiting for their response, only to have to do the testing anyway?

Alright that’s enough, thanks for reading….let me know if you have any least burdensome stories to share. This is for med device but any experience would be good to hear. I’m happy to be wrong if it’s actually a lever worth pulling!