An update on my struggle with step 1 of the FDA's 15 step flowchart

Just a quick update. I sent in my letter on December 29, but still haven’t heard back from the FDA.

So, I called the guy directly who processes the letters and puts the information in the letters in the FDA’s database, who’s the same guy in charge of the full-time help desk. He told me he hasn’t received the letter yet, and asked me to email him the letter so he can confirm it’s not on his desk. I did, and then he said it’s definitely not there yet, but he’ll let me know when it is. To be clear, he is the only person who will need to do anything with my letter once it gets past the FDA’s mailroom.

I emailed him to ask him if there’s literally any way I can just email the letter directly to him or anyone else. I haven’t heard back but I assume the answer is no. After all, the whole point of the letter is to announce to the FDA that you intend to submit items electronically from now on. We can’t be officially emailing the FDA before we send them a letter announcing our intentions to do so.

Sigh…