Device Enforcement in 2020 and the Journey Forward

On February 24, 2021, Brady Mickelsen, an Associate in the FDA Regulatory & Enforcement Practice, will host a webinar that will explore enforcement trends for device manufacturers and related establishments over the last year.  This presentation will summarize lessons learned and expectations in the year ahead and highlight future risk areas, including potential changes resulting from the new Biden-Harris Administration.

This webinar will also cover the importance of assessing risks associated with disruptions caused by COVID-19, including those related to manufacturing, quality, and post-market 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 those risks. This webinar is intended for device manufacturers’ Management, Legal, Quality, Regulatory, and Compliance teams.

Top Five Benefits

1. FDA’s areas of focus in medical device oversight and enforcement during 2020
2. The impact of COVID-19 on medical device enforcement trends in 2020 and beyond
3. FDA’s enforcement mechanisms and the Agency’s evolving use of those tools
4. The potential role of the states in medical device enforcement
5. Steps that can be taken to reduce the risk of enforcement actions