Impact of the Change in Administration on FDA’s Regulation of Devices and Digital Health

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.