The second Trump administration already left a large footprint on the administrative state as it took on trading nations with tariffs that affect device makers. Among these controversies is the question of whether gender should be included in regulatory considerations, such as in the case of a recent update on a 2014 guidance that has been removed from the device guidance webpage.

We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two stories about medical devices that either emerged or resurfaced in the merry month of May, each of which involves a cardiologist and what some of us now think of as not-so-social media. Cabana and the case for catheter ablation We’ve all heard at least a little of the noise about catheter ablation for atrial fibrillation over the years, including assertions...

Life has a lot of unknowns, and one of the big unknowns for 2019 is what the FDA will look like now that Scott Gottlieb has returned to the American Enterprise Institute. Norm Sharpless of the National Cancer Institute has been named the acting FDA commissioner – which by itself doesn’t mean a whole lot, other than that he has to be considered a lead candidate for the job – but the difficulty in knowing where the agency would go in terms of policy under...

Now that the dust is still swirling over the news that Scott Gottlieb will leave the FDA, it’s time to conduct a hasty post-mortem on his tenure at the agency, or perhaps more to the point, his lack of tenure. While it’s tempting to frame the question that way, it might be more salient to ask about the nature of the FDA commissioner’s job and whether it is still sufficiently politically insulated to do what is asked of it. Gottlieb had been on the job...