speaker-info

Kevin Go

FDA, Division of Orthopedic Devices

Kevin Go joined FDA in 2014. Kevin has served as a pre- and post-market reviewer as well as Magnetic Resonance (MR) safety focal point for the Division of Orthopedic Devices. His specific interests are in knee and shoulder arthroplasty devices. In addition to his review work, Kevin serves as a policy advisor to the CDRH Innovation group and Payors Communication Task Force, which oversees the Parallel Review and Pre-sub with Payors programs. Prior to FDA, Kevin worked at Baxter International Inc, in the infusion pump division, and Novinoor, a small start-up company focused on wearable biosensors. Kevin received his degree in Biomedical Engineering from Northwestern University and is currently pursuing his MBA at Johns Hopkins Carey Business school.

My Sessions

FDA – Regulatory Requirements: Devices

Coronado Room

This session will go over early regulatory assistance and education programs at CDRH, tips on what to include in your pre-submission/pre-market applications and considerations beyond the device approval/clearance process (i.e., payment/reimbursement).

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