I passed Step 1 of the FDA's flowchart!
Today, I got the magical news that the FDA has finally entered my company’s name into their system. Ordinarily, this would now mean that I now need to do the other 14 steps in the flowchart to submit documents.
However, fortunately, it also means that I can now hire a consultant to submit a letter of authorization that allows his company to submit on behalf of mine. He has already done that (electronically, no less).
So, assuming nothing crazy happens, I will never have to submit anything to the FDA electronically ever again. Instead, I will email pdfs to a consultant, who will charge my company $150/hr to submit these pdfs electronically. The first document he will submit will be a fee waiver request, asking the FDA to not charge my company $130k/year for the privilege of being on their radar.
Good luck 🤞