MedCon 2024, co-sponsored by the FDA

Back to MedCon Agenda 2024

April 25, 2024

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1:00 pm

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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