Description: This presentation will provide basic instruction on completing a 510k using the eSTAR submission process. Instruction includes technological advantages and efficiencies of the program, including the avoidance of common pitfalls. The presentation will include links and access to features and FDA guidances.
Learning Objectives:
Understand the purpose of eSTAR, including the differences between eCopy submission and eSTAR submission
Basic steps required to complete an eSTAR submission
Take advantage of eSTAR efficiencies and avoid common pitfalls.
