Like no other year before, 2020 shined a light on medical devices, their place in the delivery of health care, and their oversight. Along with this unusual level of attention came a unique enforcement landscape for device manufacturers. During this webinar, we will explore enforcement trends for device manufacturers and related establishments over the last year, summarize lessons learned going into 2021, and identify key future risk areas, including potential changes as a result of the new Biden-Harris Administration. We will also discuss the importance of assessing risks associated with disruptions caused by COVID-19, including those related to manufacturing, quality, and postmarket surveillance. Participants will gain an understanding not only of the risks they are likely to face in 2021 but also of the tools and systems available to mitigate against those risks. This webinar is intended for members of device manufacturers’ Management, Legal, Quality, Regulatory, and Compliance teams.
Top Five Benefits
- FDA’s areas of focus in medical device oversight and enforcement during 2020
- The impact of COVID-19 on medical device enforcement trends in 2020 and beyond
- FDA’s enforcement mechanisms and the Agency’s evolving use of those tools
- The potential role of the states in medical device enforcement
- Steps that can be taken to reduce the risk of enforcement actions