Thanks for the link. The DEKA arm is a great piece of tech.

I could speculate that because it relies on new tech and new research into prosthetic devices that the didn't just rubber stamp it.

Part of what the FDA does is safety, and the other part is validating the claims that a device or drug manufacturer makes. It's probably for this reason that they imposed additional regulatory validation. Because a cyborg arm? That HAS to be SCI-FI, right? ;)