Upcoming webinars
Live Webinar
The eSTAR Submission Program for 510(k)s, IDEs, De Novos, PMAs, and Q-Submissions
insert_invitation Monday, 31st August, 2026
access_time 1:00 PM | 10:00 AM
timelapse 60 with 15 of Q and A
Speaker/Presenter
Short Abstract
The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process; 510(k)s now can only be submitted to the FDA under the eSTAR (electronic Submission Template And Resource) Portal. Other submissions will be phased in using new guidance templates as they become available.
Who should attend
Regulatory Affairs Professionals Quality Assurance & Control Managers Compliance & Legal Officers Research & Development Engineers Executive Management & Operations Leaders
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