2022 Outlook and Updates for the US Food and Drug Administration

Regulatory expectations around the world continue to change with time and experience, and the US FDA provides significant guidance on their expectations. This webinar reviews recently released and expected guidance documents, the growing use of real-world evidence and regulatory science tools in submissions, and expectations for 2022 and beyond.  

This webinar discusses the current state of the US FDA and key forces shaping that medical device market today, including: 

  • New and updated guidance documents that are expected to be published in 2022
  • Using real-world evidence and regulatory science tools to bring products to market


This webinar is presented by Sarah Fitzgerald. She has 15 years of experience in medical device regulatory and quality affairs, including supporting products from concept to end-of-life, regulatory strategy and submissions, including more than 20 pre-market submissions to the FDA and six Emergency Use authorization (EUA) submissions. She is the US Regulatory Program Manager and a senior consultant, Quality and Regulatory Affairs at Emergo.

This webinar was recorded on March 10, 2022.