Interpreting the FDA Guidance for the Artificial Pancreas

What exactly has stalled the FDA’s approval for studies to move ahead for the Artificial Pancreas Device System* (APDS)?  Essentially, the FDA could not decide how a protocol for the APDS study should be designed.  Guess what?  Yesterday (December 1, 2011) the FDA submitted a draft guidance document for implementation of an IDE (International Device [...]