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Adobe content preparation process12/12/2022 Guided construction for each submission section.Integration of multiple resources (for example, guidances and databases).Content and structure that is complementary to CDRH internal review templates.Automation (for example, form construction and autofill). The eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. Starting October 1, 2023, all 510(k) submissions, unless exempted*, must be submitted as electronic submissions using eSTAR. OctoThe FDA is announcing that you may now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal ("CDRH Portal").īuilding on the progress tracker for 510(k) submissions launched in 2021 and the trial process of electronic uploads launched in July 2022, the CDRH Portal now allows anyone to register for a CDRH Portal account to send CDRH eCopy or eSTAR premarket submissions online. Send Medical Device eSTAR and eCopy Premarket Submissions Online
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