April 25, 2024
@
1:00 pm
-
2:00 pm
The Current State of Biocompatibility: Experience and Expectations
Pre Market Track
Listen to the current expectations – directly from FDA leaders – for what should be included in FDA premarket submissions to support device biocompatibility. Also hear updated trends experienced from the perspective of test lab experts as well as industry leaders’ experience with the preparation and submission of biocompatibility data to support both U.S. and EU MDR device submissions.
Moderator
Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS Corporation
Speakers
Jennifer Goode, Biomedical Engineer, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA
Jim Kleinedler, Director, Regulatory Strategy, Medtronic
Thor Rollins, Vice President, Global Market Segment Leader—Medical Device, Nelson Labs