On September 28, 2022, the European Commission adopted two proposals that adapt liability rules to the digital age, circular economy and the impact of global value chains. These proposals are related to (i) the Revised...more
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