Post Marketing Issues for Medical Devices: An Introduction

Review the definitions and purposes of complaint handling, Medical Device Reporting (MDR), recalls, corrections and removals, safety alerts, and ongoing monitoring/ postmarket surveillance. Examine risk communication initiatives.

Marc J. Scheineson, Partner, Alston & Bird LLP
Benjamin Wolf, Senior Associate, Alston & Bird LLP

This session was recorded as part of FDLI's Virtual Introduction to Medical Device Law and Regulation Course in April 2020. 

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