Tag: Customer Collaboration Portal

eSTAR Project Management

Medical Devices December 5, 2023

Using the new FDA eSTAR template also requires a new process for eSTAR project management to prepare your 510k and De Novo submissions. Outline of...

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FDA User Fees for FY 2024 released on July 28, 2023

Medical Devices July 29, 2023

FDA Pre-Submission Format and Content Requirements

Medical Devices June 28, 2023

510k Electronic Submission Guidance for FDA 510k Submissions

Medical Devices November 8, 2022

FDA CCP now accepts FDA eSTAR & eCopy

Medical DevicesJuly 24, 2022

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