There’s a saying that elections have consequences, an observation that has special meaning for the highly regulated medical device industry. Here are a few things for device makers to bear in mind as 2012 gives way to 2013. Supreme Court vacancies: Is PMA pre-emption back in play? The last time the U.S. Supreme Court reviewed FDA’s pre-emption of state regulatory mechanisms for PMA devices was Riegel v. Medtronic in 2008, and the decision came out in favor of the defendant. We previously discussed how the election might converge with retirements on the Supreme Court, but industry cannot assume pre-emption is...