Navigating the FDA's new Medical Device
Safety Action Plan plus...Staying Ahead of Class
Actions in Life Science
Date: Tuesday, May 22, 2018
Time: 11 am PT/ 1 pm CT / 2 pm ET
Presenters: Kim Schmid, Michelle Gilboe
On April 17, 2018, FDA released its new Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health. This FDA initiative focuses on the total product life cycle (TPLC) from clinical trials through post market surveillance. The Plan includes new information impacting manufacturers and insurers of medical devices, and incorporates five key objectives aimed at device innovation, emerging technologies, increasing patient access and increasing safety profiles. The agency is taking a deeper dive into advancing medical device cybersecurity through several key actions -- one area garnering significant attention is the development and requirement of a Software Bill of Materials. This webinar will examine all aspects of the new Medical Device Safety Action Plan, and provide thought-leadership related to its impact on future claims and litigation trends.
While Life Sciences companies have not seen the same level of class actions as other industries, they do exist. In this webinar we will also discuss the current landscape and recent class action trends in Life Sciences, help you identify the warning signs that a class action is imminent, and importantly, provide strategic insights on how to defend against a class action.