BOT - Anything but charting, page-6487

They did have the handwashing warning on their instructions, Micko, and they had also completed a human factors analysis with the instructions they submitted - it just wasn't large enough for the FDA's liking (as well as them requiring some obscure reference to a part on the device itself, oh, and they wanted portrait format, not landscape). That's what the FDA lawyer said was surprising and he thought the FDA was being pedantic, but he also noted that that's the FDA being a bureaucratic beast that punters like BOT are simply subjected to.

In short, the expert FDA lawyer didn't think it was management's fault at all and just wrote it off to unfortunately, the FDA having all the power and if that's what they want, unfortunately that's what BOT have to provide them!