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eCopy
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...
Top News
CSIR NET Dec 2023 Exam Dates Released By CSIR-HRDG – Check Now!
Biotechnology
September 21, 2023
FDA Pre-Submission Format and Content Requirements
Medical Devices
June 28, 2023
FDA on 510(k) and Review Clock: MDUFA Goals
Medical Devices
February 9, 2023
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510k Electronic Submission Guidance for FDA 510k Submissions
Medical Devices
November 8, 2022
Posted by Rob Packard on November 8, 2022 This article provides an overview of the new 510k electronic submission guidance document that...
FDA CCP now accepts FDA eSTAR & eCopy
Medical Devices
July 24, 2022
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