Victoria Calhoon

Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA...more By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering...more As noted in two prior posts, one on May 15, 2020, and the other on May 29, 2020, the COVID-19 pandemic and the resulting explosion in the use of remote depositions present a number of novel issues for lawyers to consider,...more Medical supply shortages have been in the limelight since COVID-19 barreled into the U.S. and many manufacturers have been doing all they can to answer the call for more supplies. In response to this issue and recently passed...more