Webinars
Impact of the Change in Administration on FDA’s Regulation of Devices and Digital Health
Wednesday, March 10, 2021 |
01:00 PM - 02:00 PM ET |
12:00 PM - 01:00 PM CT |
10:00 AM - 11:00 AM PT |
Our Participants
Michele L. Buenafe, Dennis C. Gucciardo, Maria Kalousi-Tatum
During this webinar, we’ll discuss what we are paying attention to with the Biden administration Food and Drug Administration (FDA).
Topics will include:
- Changes in FDA leadership and culture
- Developments in FDA’s approach to regulating LDTs and digital health
- FDA enforcement activity, both during and after the pandemic
- The much anticipated release of FDA’s alignment of the Quality System Regulation (QSR) to ISO 13485:2016
QUESTIONS?
To access slides from this webinar, please contact Erin Beck.
CLE credit: CLE credit in CA, IL, NY, PA, TX, and VA is currently pending approval. Credit in CT, FL, and NJ is pending approval (via reciprocity).