Medical Device Single Audit Program: FDA Engagement

This video—which explains the significance of FDA engaging with other recognized regulatory authorities in the Medical Device Single Audit Program—is an excerpt from the FDA Shared Inspections on the Horizon - Risks, Benefits and Impact webinar from the Xavier Health Third Thursday Lunch & Learn. The webinar features Kim Trautman, a foremost expert on where FDA is going with a shared inspection model. She has led FDA efforts in the Medical Device Single Audit Program (MDSAP) development with other recognized regulatory authorities since its inception. While in FDA, she spearheaded this work with her international regulator colleagues by chairing the MDSAP Working Group for the International Medical Device Regulators Forum. Now in her role as Executive Vice President for NSF International, Kim will candidly share what she sees as the benefits and risks of this program to FDA, the benefits and risks of this program to industry, and the hurdles that have to be overcome in order for this program to succeed.