April 25, 2024
@
2:20 pm
-
3:40 pm
Medical Device Sterilization Sustainability: EPA’s New Rule, FDA Initiatives, and Industry’s Challenges
Plenary Session
Session participants will gain understanding of the EPA EtO NESHAP Rule, FDA initiatives to strengthen sterilization sustainability, challenges and considerations for industry with alternative technologies, and watchouts and risks with FDA and industry experts.
Moderator
Bill Brodbeck, Senior Director, Regulatory Affairs, STERIS Corporation
Speakers
Mark Leahey, President & CEO, Medical Device Manufacturers Association (MDMA)
Brian McEvoy, Senior Director Global Technologies, Steris
Ryan Ortega, Regulatory Policy Advisor, Office of Product Evaluation and Quality (OPEQ) at the Center for Devices and Radiological Health (CDRH), FDA
Suzanne Schwartz, Director, Office of Strategic Partnerships & Technology Innovation, Center for Devices and Radiological Health (CDRH), FDA