The playwright George Bernard Shaw is credited with having said, “the single biggest problem in communication is the illusion that it has taken place,” a remark device makers might apply to their interactions with FDA and the Centers for Medicare & Medicaid Services. Those two agencies might have similar observations about device makers, too. Still, we’ve all discovered it’s not always easy to communicate clearly, especially when complex matters are at hand. So let’s dig into the story behind a recent development at FDA and a long-standing communication hurdle between CMS and device makers. FDA recently issued a draft standard...