I am so f'ing brilliant

Hey! Said I. I said, Hey! There's a whole lotta FDA hoop-jumping we have to do here, before we can do this other thing you want me to do.

So guess who's in charge of mapping out all those hoops? That's right, me.

The search for the government's definition of "medical device" has taken me half an hour of combing through the CFR database. Make that even longer, because the link that was supposed to take me to 21 CFR 201(h) has apparently been erased from the intertubes. Shit... Oh, look! Lazarus link! It's aliiiiiive. Finally!

I've read multiple guidances, and have tried to distill them into something palatable, but it's damn near impossible with some of these things. I'm sorry, you just have to read the whole thing, guys.

9:15 and I want a mojito. And a beach. And my well-tanned man in white shorts, rubbing scented oils into my skin...

*sigh* I'll just take a moment and go to my happy place.

ETA: Ok, so I'm scrolling through the index for 21 CFR (parts 1 to 1499, thankyouverymuch) and come across (332) Antiflatulent products for over-the-counter human use. That's right, the Beano regulation!

Nothing makes you lean libertarian like reading through the CFR. My god.

Well got dam, if I didn't just do it to myself again.

Somebody stop me. Please.

A new grant mechanism came out (thanks again, ARRA 2009), it looks like a great alternative to the mechanism we were pursuing.

I had to go and say so.

The reply: "Great we will do both. I will explain get ready for some hard work."


NOOOOOOOOOOoooooooo!

I can see where we can do both. I can. I just wish I could stop making so much work for myself.

Let's think of something more pleasant, shall we?

First, I want to share a little story. When I was a wee thing, my parents used to try to convince me that I was really a boy. We found you under a rock, and you had a tail, they'd say, and we wanted a girl so much that we grew your hair long and put you in dresses.

I did indeed have long hair. It was so long, I used to sit on it. And I did like to wear dresses. One evening, when I was five or so years old, my parents were again telling me the story of how they found me under a rock. This evening, though, I pointed out that Nuh uh, I'm not a boy! I don't have what daddy has! I don't stand up to pee!

And so ended the game.

I thought it may be fun to play with my kids someday, and tell them that they were really girls. To bolster my argument in a way my parents didn't think of, I am gathering ( photographic evidence )