Developments in the health care industry and advances in medical device technology often lead to new regulatory requirements and alternate forms of evidence generation. Guidelines from different authorities are often complementary, but there are differences that manufacturers should understand in order to stay competitive internationally. In this session, speakers will discuss new FDA guidance documents and CDRH priorities, as well as regulations and guidelines in other regions. The utility and appetite for patient preference data continues to grow, along with the methods for analyzing such data. Developments in the collection and use of patient preference data as part of an evidence generation strategy will also be discussed.
