The soon-to-end calendar year 2018 was a busy one for a number of federal agencies with a lot to say about the world of medical devices, particularly for the U.S. FDA. However, the most interesting stories about the FDA's device center might be about what the agency has not done or hinted that it might do, rather than what it actually got around to doing over the past 12 months, including the still-absent pilot program for software pre-certification.